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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 Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 02/01/2020
Event Type  malfunction  
Manufacturer Narrative
A third party service agent evaluated the customer¿s device and verified the reported issue.The service agent replaced the device¿s therapy pcb assembly.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
 
Event Description
A customer contacted physio-control to report that their device had a partial loss of defibrillator output, as it was delivering monophasic defibrillation energy.In this state, the defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
 
Event Description
A customer contacted physio-control to report that their device had a partial loss of defibrillator output, as it was delivering monophasic defibrillation energy.In this state, the defibrillator output energy could be reduced by up to approximately 20% from the selected energy level.There was no patient use associated with the reported event.
 
Manufacturer Narrative
The removed therapy pcba was further evaluated by the failure analysis center (fac) and the reported issue could be duplicated.Further testing revealed that the energy waveform was monophasic in natural with about 82% of it energy delivered, also gave "abnormal energy delivery" message.Root cause was identified as a short on pins 5 to 9 on diode, designator cr30.
 
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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 Key9751299
MDR Text Key190963071
Report Number0003015876-2020-00268
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 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000019
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2020
Initial Date Manufacturer Received 02/03/2020
Initial Date FDA Received02/25/2020
Supplement Dates Manufacturer Received04/08/2020
Supplement Dates FDA Received05/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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