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LifePak CR Plus Automated External
Defibrillators AED |
Physio Control, Inc., issued a recall of
LifePak CR Plus Automated External
Defibrillators (AED,
used by emergency or medical personnel to
treat adults in cardiopulmonary arrest. The
product was recalled because the AED
instructs the responder by voice prompts to
press the shock button which is not visible
because it is covered, thereby making the
responder unable to provide shock therapy.
The AED device should be removed from
service or the manufacturer-provided diagram
should be consulted to remove and discard
the shock button cover.
Read the entire 2008 MedWatch Safety
Summary, including a link to the
manufacturer's Recall Notice regarding this
issue:
Recall: ontrol, Inc. LifePak CR Plus
Automated External Defibrillators (AEDs)
Class 1 Recall: Physio Control, Inc.
LifePak CR Plus Automated External Defibrillators (AEDs)
| Date Recall Initiated |
August 28, 2008 |
|
Product: |
LifePak CR Plus Automated External
Defibrillator
Product Number: 3200731-003 and
3200731-027
This device was manufactured from
May 20, 2004 through August 11, 2007
and distributed from May 20, 2004
through December 4, 2007. |
|
Use: |
These devices are used by emergency
or medical personnel, or by others
who have taken the appropriate
training to use this AED. The
devices are intended to treat adults
in cardiopulmonary arrest (heart
attack). They analyze an unconscious
patient’s heart rhythm and
automatically deliver an electrical
shock to the heart if needed to
restore normal heart rhythm. |
|
Recalling Firm: |
Physio Control, Inc.
11811 Willows Rd NE
Redmond, Washington 98052-2003 |
|
Reason for Recall: |
The AED instructs the responder, by
voice prompts, to press the shock
button. However, the shock button is
covered and is not visible.
Therefore, the responder is not able
to provide therapy (shock). |
|
Public Contact: |
Customers with questions may call
Physio Control, Inc. at
1-425-867-4000, extension 4644.
|
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FDA District: |
Seattle |
|
FDA Comment: |
Physio Control began calling their
customers on August 28, 2008 and:
-
described the problem of the
covered and invisible shock
button, and the inability to
provide shock to adults who may
be having a heart attack.
-
informed their customers that
their AEDs would be replaced
immediately.
-
sent a follow-up letter that was
FAXed or emailed the same day
stating that the customers
should immediately perform
one
of the following actions:
-
Remove the affected AEDs
from service
or
-
Remove and discard the shock
button cover (a diagram
showing what to do was
enclosed).
The company completed notifying its
customers on September 2, 2008
Healthcare professionals and
consumers may report any problems
with the use of this product to the
FDA's MedWatch Adverse Event
Reporting program either online, by
regular mail or by FAX.
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