> July 22, 2002

Item: SSCOR Incorporated, Suction Pumps, Models 2314, 2314B and 2315,
all units.

Specific Incident: These pumps are designed for short-term suction,
primarily during resuscitation efforts, yet one medical center used them
for extended procedures, such as wound drainage and endoscopic
procedures, resulting in pump failures. Use of these pumps for extended
high vacuum/high occlusion can lead to overheating and premature pump
failure, making the equipment unavailable for use and limiting needed
suction.

Recommendations: 1.**Check** the medical equipment inventory to
determine if you have the specified pumps. Model numbers for the SSCOR
suction units can be found on a silver label on the back of the units.
Ensure any units on hand are being used as intended, and not placed in
areas where they can be used for long term or continuous suction.

> 2\. **Refer** to the revised page 3 of the operator and service
> manuals (attached), copy and insert the revised pages in all SSCOR
> 2314, 2314B and 2315 operator and service manuals. If manuals are not
> available they can be obtained from the manufacturer or from the
> Center for Engineering and Occupational Safety & Health (CEOSH) at
> (314) 543-6700 or at
> [http://vaww.ceosh.med.va.gov](http://vaww.ceosh.med.va.gov/).
>
> 3\. **Label** pumps to reflect intended use: "CAUTION: Not for
> continuous suction; for short term use only."
>
> 4\. **Train** users on the intended use of these pumps and the
> possible risk associated with use beyond the equipment's design. If
> necessary, purchase appropriate suction systems for wound or
> procedural drainage

Source: CEOSH and manufacturer

Contact: For additional information, please contact Mr. Paul Sherman at
CEOSH (314) 543 6700.

URGENT FIELD CORRECTION

July 1, 2002

Subject: Field Correction Notice for S-SCORT new-Duet and new-Sentinel
Suction Units sold exclusively through Armstrong Medical Industries.

To Whom It May Concern:

SSCOR needs your prompt cooperation in carrying out an urgent field
correction. Based on reports from the field, our company has become
aware of instances where some of the suction units referenced below have
been used in medical procedures for which they were not designed or
intended. In evaluating these reports we have determined it would be
appropriate to make the intended use of our devices even more specific.
These events have been reported to United States Food and Drug
Administration (FDA), and FDA is aware of our corrective action.

The corrective action specifically affects all SSCOR suction units sold
through Armstrong Medical Industries with the following model numbers:

SSCOR Suction Unit Model 2314 (AE 6975 or 6975S)

SSCOR Suction Unit Model 2314B (AE 6976or 6976S)

SSCOR Suction Unit Model 2315 (AE 6905)

Model numbers for these SSCOR suction units can be found on a silver
label on the back of the units.

Because of what we have learned, we are adding the following cautionary
language to page 3 of the General Description portion of the Operating
Instructions and Maintenance Manual:

\"CAUTION: S-SCORT suction units are designed for hospital crash cart
suction, patient transport and emergency medical service. They are not
designed or intended for use in extended procedures that require
prolonged high vacuum/low airflow applications, as is the case in wound
drainage or endoscopic use or in any other procedure that produces high
vacuum levels within an occluded system for an extended period of time.
Turn the S-SCORT suction unit off when it is not in use.\"

Attached to this letter is a revised page 3 for your Operating
Instructions and Maintenance Manual. Please make certain that a copy of
this new page is inserted into the Manual for each suction unit. If
necessary, SSCOR will provide you with additional copies of the revised
manual page. In addition, we ask that you make the revised portion of
the Manual part of a notice alerting all users of these devices in your
facility to the appropriate intended use for our products.

If you have any questions regarding the contents of this letter or any
questions as to how to carry out this field correction, please contact
our Customer Service at 1-800-434-5211.

We appreciate your full cooperation in this matter.

Sincerely Yours,

Scott Eamer

Product Manager

SSCOR, Inc.

WWW.SSCOR.com

**[Table of Contents]{.underline}**

S-SCORT newDuet Model 2314

  ----------------------------------- -----------------------------------
  Caution-Notice                      2

  General Description and Symbols     3

  Getting Acquainted- Basic           4
  Instructions                        

  General Specifications-Trouble      5
  Shooting                            

  Warranty-Maintenance                6

  Internal Access-Internal Components 7

  Conformity                          8
  ----------------------------------- -----------------------------------

**[General Description]{.underline}**

S-SCORT newDuet Model 2314

S-SCORT newDuet is a portable, 100V-240V AC constant suction device,
with a

12V DC battery back-up. The battery is charged by an internal, DC Dual
Mode battery charger. A fully charged battery will power the unit for 45
minutes (+-10%). Battery condition is automatically monitored and
visualized by indicator lights on the control panel. AC charging should
bring the battery to a dependable working charge in 6 to 8 hours.

Suction power can be regulated when full power may be considered harmful
to the patient.

CAUTION: S-SCORT suction units are designed for hospital crash cart
suction, patient transport and emergency medical service. They are not
designed or intended for use in extended procedures that require
prolonged high vacuum/low airflow applications, as is the case in wound
drainage or endoscopic use or in any other procedure that produces high
vacuum levels within an occluded system for an extended period of time.
Turn the S-SCORT suction unit off when it is not in use.

**[Description of Symbols]{.underline}**

S-SCORT newDuet Model 2314

[Symbol Location Meaning]{.underline} ![](media/image2.png)

**[Table of Contents]{.underline}**

S-SCORT *new*-Sentinel® Model 2315

  ----------------------------------- -----------------------------------
  Caution-Notice                      2

  General Description and Symbols     3

  Getting Acquainted- Basic           4
  Instructions                        

  General Specifications-Trouble      5
  Shooting                            

  Warranty-Maintenance                6

  Internal Access-Internal Components 7

  Conformity                          8
  ----------------------------------- -----------------------------------

**[General Description]{.underline}**

S-SCORT *new*-Sentinel® Model 2315

The S-SCORT *new*-Sentinel™ is a portable, 12V DC battery operated
suction pump. It is powered by sealed lead acid batteries, capable of
driving the unit at full power for 30 minutes 10%. The batteries are
recharged by a 115V AC to 13.8V DC Dual Mode Automatic Charger (included
with the unit).

CAUTION: S-SCORT suction units are designed for hospital crash cart
suction, patient transport and emergency medical service. They are not
designed or intended for use in extended procedures that require
prolonged high vacuum/low airflow applications, as is the case in wound
drainage or endoscopic use or in any other procedure that produces high
vacuum levels within an occluded system for an extended period of time.
Turn the S-SCORT suction unit off when it is not in use.

The *new*-Sentinel™ is designed to provide instant, effective
suctioning, independent of external sources of power and can be pre-set
to be activated immediately upon reaching the distressed patient.

Suction power is controllable for those instances when full power would
be considered harmful to the patient.

The S-SCORT *new*-Sentinel™ is equipped with a disposable collection
canister which features a bacterial filter to screen airborne
particulates and a mechanical shut-off valve to prevent fluid overflow.

**[Description of Symbols]{.underline}**

S-SCORT *new*-Sentinel® Model 2315

# Symbol Meaning Location

![](media/image3.png)