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

Model Number	15
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control evaluated the customer's device and was able to verify the reported issue.Physio replaced the therapy pcb assembly, which resolved the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.
Event or Problem Description
The customer contacted physio-control to report that their device's service light is illuminated.Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory that is related to a potential failure of the device to display ecg in paddles lead.As a result, defibrillation may be delayed or prevented if it had been necessary.There was no patient involved in the reported event.
Additional Manufacturer Narrative
Physio-control further evaluated the removed therapy pcb assembly and found that the cause of the reported issue was due to a current leakage from a capacitor, designator c160.
Event or Problem Description
The customer contacted physio-control to report that their device's service light is illuminated.Upon evaluation of the customer's device, physio-control observed an event code logged in the device's memory that is related to a potential failure of the device to display ecg in paddles lead.As a result, defibrillation may be delayed or prevented if it had been necessary.There was no patient involved in the reported 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: 7733474
• Report Number: 0003015876-2018-01208
• Device Sequence Number: 19173796
• Product Code: MKJ
• UDI-Device Identifier: 00883873988114
• UDI-Public: 00883873988114
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2018

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: 99577-000037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Initial Date Received by Manufacturer: 07/16/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1