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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control provided the biomed with technical assistance.The device has not been returned to physio-control.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer, a biomedical engineer, contacted physio-control to report that their device power on/off button is hard to activate.As a result, defibrillation may be delayed or prevented if it had been necessary.There was no patient use associated with the reported event.
Event or Problem Description
The customer, a biomedical engineer, contacted physio-control to report that their device power on/off button is hard to activate.As a result, defibrillation may be delayed or prevented if it had been necessary.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control was later made aware by the customer, a biomedical engineer, that the main keypad assembly was replaced to resolve this issue.The removed part was not returned to physio for evaluation, therefore further cause could not be determined.

• 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: 8269085
• Report Number: 0003015876-2019-00119
• Device Sequence Number: 2120537
• Product Code: MKJ
• UDI-Device Identifier: 00883873911730
• UDI-Public: 00883873911730
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2019

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: 99577-001246
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1