510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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Z-1656-2008

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

Physio Control, Inc. / initiated 2008-02-27 / Terminated
FDA source (opens on fda.gov)

Physio Control, Inc. began a recall of LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator... on . The reason FDA records is "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...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1656-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Physio Control, Inc.
Product
LIFEPAK 1000 defibrillator - portable battery powered semi-automated model that can be operated in either of three modes: Automated external defibrillator (AED), manual defibrillator and electrocardiographic (ECG) mode. The defibrillator is intended for indoor or outdoor use in a wide variety of hospital and pre-hospital settings including ground and air ambulances, physician's offices, aircraft, stadiums and specialty medical clinics. ECG monitoring is intended for use on conscious and unconscious patients of all ages for the purpose of ECG rhythm recognition and heart rate monitoring. Affected part numbers: 320371500021 through 320371500038, 320371500043, 320371500044, 320371500046, 320371500048, 320371500050, 320371500056, 320371500058, 320371500063, and 320371500067.
Product code
MKJ Automated External Defibrillators (Non-Wearable)
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.
FDA root cause
Component change control
Action
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.
Quantity in commerce
1,647 total - 426 US, 1,221 international
Distribution
Worldwide Distribution --- including USA and countries of Netherlands, Germany, Australia, Hong Kong, Barbados and Brazil.
Product codes and lots
Domestic: 35223068, 35267516, 35267519, 35892406, 35895430, 35242436, 35892542, 35977949, 35267533, 35267553, 35910136, 35972647, 35972648, 35972649, 35972650, 35972651, 35972652, 35972653, 35942190, 35942193, 35938673, 35223075, 35969804, 35969805, 35926650, 35926651, 35926652, 35926653, 35926654, 35926655, 35926562, 35967657, 35967658, 35967659, 35967660, 35967661, 35967664, 35967665, 35967666, 35967667, 35969810, 35969811, 35969812, 35969813, 35972478, 35972479, 35972480, 35972481, 35972482, 35904997, 35973187, 35974263, 35974264, 35974265, 35974266, 35974267, 35974268, 35969073, 35969090, 35969091, 35969092, 35969093, 35969094, 35969095, 35969096, 35969097, 35969098, 35969099, 35969100, 35969101, 35969102, 35969103, 35969104, 35969105, 35972621, 35972622, 35972623, 35972624, 35972625, 35965677, 35965678, 35965679, 35965680, 35965682, 35965684, 35965685, 35965688, 35965689, 35965690, 35967568, 35988737, 35988738, 35988739, 35988740, 35223108, 35223112, 35223114, 35220224, 35894843, 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