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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Material Fragmentation (1261)
Patient Problem No Patient Involvement (2645)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.Device not evaluated by manufacturer.
 
Event Description
The customer contacted physio-control to report that a pin from the quik-combo electrodes cable broke off in the therapy connector assembly of their device.As a result, defibrillation may have been delayed, or prevented, if it were necessary.There was no patient use associated with the reported issue.
 
Event Description
The customer contacted physio-control to report that a pin from the quik-combo electrodes cable broke off in the therapy connector assembly of their device.As a result, defibrillation may have been delayed, or prevented, if it were necessary.There was no patient use associated with the reported issue.
 
Manufacturer Narrative
Physio-control confirmed with the customer, a biomedical engineer, that the therapy connector on the device was replaced to resolve the reported issue and proper device operation was observed through functional and performance testing.The device was put back into service for use.
 
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Brand Name
LIFEPAK® 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 Key8454350
MDR Text Key139974547
Report Number0003015876-2019-00527
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00883873813799
UDI-Public00883873813799
Combination Product (y/n)N
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000033
Was Device Available for Evaluation? No
Date Manufacturer Received05/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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