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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 Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/10/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The third party service agent downloaded the device's electronic records and provided them to physio-control for review. Upon review, physio-control was able to verify 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
It was reported to a third party service agent that the customer's device would not complete the boot-up process in order to power on. The customer advised that medical personnel attempted to power the device on three times; however, each time the initial physio-control splash screen would appear and the device would power off by itself without completing the boot-up process. As a result, defibrillation would not have been possible if it had been necessary. There was patient use associated with the reported event. The patient was delivered to the hospital in stable condition. There were no reports of adverse effects to the patient as a result of the reported issue.
 
Manufacturer Narrative
The third party service agent evaluated the customer's device but was unable to duplicate the reported issue. The service agent observed that the battery pin in battery well #1 was visibly lower that the other battery pins. If the battery pin in battery well #1 was making intermittent contact with the battery, this could result in an intermittent loss of power. The service agent repaired the device by replacing the rear case assembly. Additionally, the system pcb assembly was replaced as a precaution. After observing proper device operation through functional and performance testing the unit was returned to the customer for use. The device was not returned to physio-control for evaluation. The cause of the reported issue could not be conclusively determined.
 
Event Description
It was reported to a third party service agent that the customer's device would not complete the boot-up process in order to power on. The customer advised that medical personnel attempted to power the device on three times; however, each time the initial physio-control splash screen would appear and the device would power off by itself without completing the boot-up process. As a result, defibrillation would not have been possible if it had been necessary. There was patient use associated with the reported event. The patient was delivered to the hospital in stable condition. There were no reports of adverse effects to the patient as a result of the reported issue.
 
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Brand NameLIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7657094
MDR Text Key113003284
Report Number0003015876-2018-01034
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 08/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001269
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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