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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 08/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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 not evaluated by manufacturer.
 
Event Description
The customer contacted physio-control to report that their device would not complete its self test.During initial evaluation, it was observed that the device had logged an event code which is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform. there was no patient use associated with the reported event.
 
Event Description
The customer contacted physio-control to report that their device would not complete its self test.During initial evaluation, it was observed that the device had logged an event code which is indicative of a device failure that could result in a partial loss of defibrillator output energy due to a loss of the negative portion of the biphasic output waveform.  there was no patient use associated with the reported event.
 
Manufacturer Narrative
The third-party service agent replaced the therapy pcb assembly to resolve the reported issue.Proper device operation was subsequently observed through functional and performance testing.The device was returned to the customer for use.Physio-control further evaluated the replaced therapy pcb assembly and the cause of the reported issue was determined to be due to shorted pins 5 to 9 on diode, designator cr30, which caused the device to log the event code, give an "abnormal energy delivery" message and only provide monophasic output.
 
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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 Key8977857
MDR Text Key190123375
Report Number0003015876-2019-01505
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 02/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20
Device Catalogue Number99402-000017
Was Device Available for Evaluation? Yes
Date Manufacturer Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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