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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Patient Involvement (2645)
Event Date 08/07/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was unable to duplicate the reported issue.Upon evaluation it was observed that the defibrillation energy level delivered by the device was not as expected.After replacing the therapy pcb, proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer for use.
 
Event Description
A customer contacted physio-control to report that after the depletion of the first battery, the device did not automatically switch to the second battery.The device did not recognize it's second battery during use.Upon evaluation of the customer's device, physio-control observed that the defibrillation energy level delivered by the device was not as expected.As a result, wrong defibrillation therapy may be delivered, if needed.There were no reports of patient use associated with the reported event.Physio-control contacted the customer in order to obtain additional information about patient involvement and event; however, no response was received.
 
Manufacturer Narrative
Stryker further evaluated the removed therapy pcb assembly and was unable to duplicate the reported issue.The cause of the reported issue was determined to be due to the therapy pcb assembly.
 
Event Description
A customer contacted physio-control to report that after the depletion of the first battery, the device did not automatically switch to the second battery.The device did not recognize it's second battery during use.Upon evaluation of the customer's device, physio-control observed that the defibrillation energy level delivered by the device was not as expected.As a result, wrong defibrillation therapy may be delivered, if needed.There were no reports of patient use associated with the reported event.Physio-control contacted the customer in order to obtain additional information about patient involvement and event; however, no response was received.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key8956649
MDR Text Key156408591
Report Number0003015876-2019-01466
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 11/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001449
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Date Manufacturer Received11/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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