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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2020
Event Type  malfunction  
Manufacturer Narrative
Third party service agent evaluated the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.
 
Event Description
The third party service agent contacted physio control to report that their customer device had a broken pin in the therapy connector and would not recognize a connection through its therapy connector.In this state, the device would not be able to provide defibrillation therapy, if it were needed.There was no reports of patient use associated with the reported event.
 
Event Description
The third party service agent contacted physio control to report that their customer device had a broken pin in the therapy connector and would not recognize a connection through its therapy connector.In this state, the device would not be able to provide defibrillation therapy, if it were needed.There was no reports of patient use associated with the reported event.
 
Manufacturer Narrative
The root cause of the reported issue was determined to be a broken pin/ connector in the therapy connector.After the therapy connector was replaced and some other unrelated repairs were performed, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.
 
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Brand Name
LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key11023189
MDR Text Key222038457
Report Number0003015876-2020-01899
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 03/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2020
Date Manufacturer Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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