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

Model Number	15
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physio-control evaluated the customers device and was unable to verify the reported issue.The cause of the reported issue could not be determined.During evaluation physio found an error code logged in the memory of the device.The event code logged is related to a potential failure of the device to deliver defibrillation energy.Physio replaced the device¿s main keypad assembly.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.Based on the information available, physio-control has determined that the likely cause of the noted event code 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.
Event or Problem Description
The customer contacted physio-control to report that their device gave the "disarming" message when calibrating.In this state the device may not be able to deliver defibrillation therapy if needed.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 patient use reported with the 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: 9826303
• Report Number: 0003015876-2020-00366
• Device Sequence Number: 16911437
• Product Code: MKJ
• UDI-Device Identifier: 00883873911556
• UDI-Public: 00883873911556
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 03/12/2020

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: 99577-001263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/12/2020
• 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