MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device and verified the reported issue.The customer declined to have their device repaired and the device was returned unrepaired to them.The likely cause of the reported issue is the system pcb assembly, however the cause could not be conclusively determined.
Event or Problem Description
The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that when attempting to power on their device it locked up at the self-test screen and would not complete a boot cycle.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Section d10 of the initial medwatch report indicates: product available to stryker? field returned to manufacturer on ¿ 03/20/2020.Section d10 of the initial medwatch report should indicate: product available to stryker? no returned to manufacturer on ¿ blank section h3 of the initial medwatch report indicates: device evaluated by mfg ¿ yes reason for no evaluation ¿ blank reason code ¿ other ¿ blank section h3 of the initial medwatch report should indicate: device evaluated by mfg ¿ no reason for no evaluation - other reason code ¿ other - device not evaluated by manufacturer section h6 of the initial medwatch report indicates: method code ¿ testing of actual/suspected device results code ¿ operational problem identified section h6 of the initial medwatch report should indicate: method code ¿ device not returned results code ¿ no findings available section h10/h11 of the initial medwatch report indicates: additional mfg narrative ¿ physio-control evaluated the customer's device and verified the reported issue.The customer declined to have their device repaired and the device was returned unrepaired to them.The likely cause of the reported issue is the system pcb assembly, however the cause could not be conclusively determined.Section h10/h11 of the initial medwatch report should indicate: additional mfg narrative ¿ the device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.H3 other text : device not evaluated by manufacturer.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
• Common Device Name: AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
• Manufacturer (Section D): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• MDR Report Key: 9930359
• Report Number: 0003015876-2020-00477
• Device Sequence Number: 644349
• Product Code: MKJ
• UDI-Device Identifier: 00883873979020
• UDI-Public: 00883873979020
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 05/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1