LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes

FDA device recall Z-1656-2008 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Physio Control, Inc.

Reason for recall

Potential for the display screen to dim and eventually go blank. The risk to patient is a delay in defibrillation therapy if the defibrillator was needed in a cardiac arrest situation. Death or permanent impairment can occur if the user fails to deliver a defibrillation shock or defibrillation is delayed.

Action taken

On February 27, 2008 the firm sent a URGENT MEDICAL DEVICE NOTIFICATION letter to consignees advising of the issue. The letter states the firm is performing accelerated function testing and that a follow up notification will be sent if the firm's final test results indicate further action is necessary. The letter recommends consignees "Continue to use your LIFEPAK 1000 defibrillator/monitor Set your device to Auto-Analyze Contact Physio-Control immediately if your display begins to dim or goes blank. What to do if the display goes blank while in use: 1. Continue to use the device to treat the patient. (voice prompts and tones function normally). 2. If the device is not set to Auto-Analyze use the lower right soft key to select Analyze from the display screen... 3. All other buttons are labeled outside the display screen." If you have any question contact technical support at 1-800-442-1142 - option 5 or visit the web site at www.physio-control-notices.com/LP1000.

Root cause

Component change control

Status

Terminated

Product code

MKJ

Quantity affected

1,647 total - 426 US, 1,221 international

Distribution

Worldwide Distribution --- including USA and countries of Netherlands, Germany, Australia, Hong Kong, Barbados and Brazil.

Date initiated

2008-02-27

Date posted

2008-09-16

Date terminated

2011-03-07

Location

Redmond, WA

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