MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATORV2; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	15
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer¿s device and verified the reported issue.Physio replaced the biphasic pcb assembly and then observed proper device operation through functional and performance testing and the device was returned to the customer for use.Physio-control further evaluated the removed biphasic pcb assembly.It was determined that the cause of the reported issue was due to electrical overstress, which resulted in diodes, designators cr7, cr24 and cr27 becoming electrically shorted.
Event or Problem Description
The customer contacted physio-control to report that their device logged non-critical event code during preventative maintenance.Upon evaluation of the customer's device, physio-control observed that the customer¿s device was unable to complete a charge for defibrillation therapy.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 15 MONITOR/DEFIBRILLATORV2
• 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: 8632128
• Report Number: 0003015876-2019-00892
• Device Sequence Number: 11266769
• Product Code: MKJ
• UDI-Device Identifier: 00883873911693
• UDI-Public: 00883873911693
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 05/22/2019

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: 99577-001250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1