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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK CR2 DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CR2
Device Problem Unintended Power Up (1162)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
Event Type  malfunction  
Manufacturer Narrative
Physio-control continues to investigate the reported failure and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The customer contacted physio-control to report that their device is repeatedly powering itself on and providing voice prompts without any user interaction.This may lead to premature battery depletion.As a result, defibrillation therapy may be delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
 
Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.Physio determined that the cause of the reported issue was due to a failed switch, designator sw5.The device was destructively tested and the customer received a replacement device.
 
Event Description
The customer contacted physio-control to report that their device is repeatedly powering itself on and providing voice prompts without any user interaction.This may lead to premature battery depletion.As a result, defibrillation therapy may be delayed or unavailable, if needed.There was no report of patient use associated with the reported event.
 
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Brand Name
LIFEPAK CR2 DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key11957891
MDR Text Key254870845
Report Number0003015876-2021-01195
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberCR2
Device Catalogue Number99512-001453
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2021
Date Manufacturer Received10/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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