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

Model Number	15
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control reviewed the device data and verified the reported issue and determined that a service event code had been logged.Based on the information available, physio-control has determined that it¿s reasonable to conclude that the likely cause of the reported issue was that the shock switch located on the main keypad assembly was out of tolerance due to excessive resistance.When this issue occurs, an event code will be logged in the device's memory following a failure of the device to deliver defibrillation energy.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.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report a non-critical issue with their device.Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory.The event code logged is related to a potential failure of the device to deliver defibrillation energy.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
The main keypad assembly was replaced and the device passed functional and performance testing and was returned to the customer for use.

• 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: 9566751
• Report Number: 0003015876-2020-00064
• Device Sequence Number: 2866668
• Product Code: MKJ
• UDI-Device Identifier: 00883873911693
• UDI-Public: 00883873911693
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2020

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: 99577-001250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/15/2019
• Supplement Date Received by Manufacturer: 03/25/2020
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 04/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3015876-11/18/2019-001C
• Patient Sequence Number: 1