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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20E
Device Problems Material Fragmentation (1261); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device was not returned to physio-control.A third-party service agent performed an initial evaluation of 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.Device evaluated by the third party agent.
 
Event Description
A third party service agent contacted physio-control to report that their customer device had broken pins inside the therapy connector.In this state device may not deliver defibrillation therapy to a patient, if it was needed.There was no reports of patient use associated with the reported event.
 
Event Description
A third party service agent contacted physio-control to report that their customer device had broken pins inside the therapy connector.In this state device may not deliver defibrillation therapy to a patient, if it was needed.There was no reports of patient use associated with the reported event.
 
Manufacturer Narrative
The third-party service agent further evaluated the customer's device and replaced the therapy connector assembly.Proper device operation was subsequently observed through functional and performance testing.The device was returned to the customer for use.The cause of the reported issue was determined to be due to physical damage to the therapy connector assembly as there was a broken pin in the socket of the therapy connector.
 
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Brand Name
LIFEPAK(R) 20E 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 Key9296124
MDR Text Key167189748
Report Number0003015876-2019-01816
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 01/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20E
Device Catalogue Number99507-000019
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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