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	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and verified the reported issue.Physio-control then replaced the device's main keypad assembly and after observing proper device operation through functional and performance testing the unit was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device's power button on the main keypad assembly had a poor response when pressed (in order to power the device off).Issues with the power button could also delay or prevent the device from powering on.There were no reports of patient use associated with the reported event.
Additional Manufacturer Narrative
It was later clarified that although it was reported that the device's power button on the main keypad assembly had a poor response when pressed, that there was no evidence that it prevented (or significantly delayed) the device from powering on or off.Physio-control further evaluated the removed main keypad assembly and confirmed that the left side of the power button had a poor response when pressed and required additional force in order to activate.The right side of the button had no discrepancies and both sides were observed to be functional.
Event or Problem Description
The customer contacted physio-control to report that their device's power button on the main keypad assembly had a poor response when pressed (in order to power the device off).Issues with the power button could also delay or prevent the device from powering on.There were no reports of patient use associated with the reported event.

• 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: 7623329
• Report Number: 0003015876-2018-00979
• Device Sequence Number: 1623751
• Product Code: MKJ
• UDI-Device Identifier: 00883873979198
• UDI-Public: 00883873979198
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2018

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: 99577-000076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 09/13/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 09/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1