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

Model Number	15
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customer's device, downloaded the device log data, and verified the reported issue.Physio also confirmed that the device did not deliver defibrillation energy.The issue was isolated to the therapy pcb.After replacing the therapy pcb, the device software was updated and the device passed functional and performance testing and was returned to the customer.
Event or Problem Description
The customer contacted physio-control to report that an event code is logged in the memory of their device.The event code logged in its memory 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, resulting in a monophasic shock.During evaluation, physio-control verified the customer reported issue and also observed another event code logged in the device's memory which is related to a potential failure of the device to deliver defibrillation energy.There was no report of patient involvement associated to this event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly and determined that the cause of the reported issue was due to shorted q7 on the h-bridge.
Event or Problem Description
The customer contacted physio-control to report that an event code is logged in the memory of their device.The event code logged in its memory 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, resulting in a monophasic shock.During evaluation, physio-control verified the customer reported issue and also observed another event code logged in the device's memory which is related to a potential failure of the device to deliver defibrillation energy.There was no report of patient involvement associated to this event.

• Brand Name: LIFEPAK 15 DEFIBRILLATOR/MONITOR
• 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: 11725409
• Report Number: 0003015876-2021-00922
• Device Sequence Number: 14426752
• Product Code: MKJ
• UDI-Device Identifier: 00883873871874
• UDI-Public: 00883873871874
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2021

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: 99577-001939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 03/31/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1