MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer, a biomedical engineer evaluated their device and verified the reported issue.The therapy pcb assembly was replaced.During the course of the repair, the biomedical engineer said that he dropped a screw inside of the device which resulted in the device rebooting itself.There was no power issues prior to working on the device.The device was sent to physio-control for further evaluation.Physio-control evaluated the customer¿s device and was unable to duplicate the reported issue.Physio did observe that the device was unable to power off.The device was disassembled and all internal connections were re-seated.After reassembling the device, proper operation was observed.After other unrelated repairs were completed, proper device operation was observed through functional and performance testing.The device was returned to the customer for use.
Event or Problem Description
The customer, a biomedical engineer contacted physio-control to report that during testing, their device was unable to detect the connection of the defibrillation therapy cable.The customer advised that the device prompted them to ¿connect cable¿.In this state, the device would be inoperable and defibrillation therapy would not be available if needed.There was no report of patient use for the reported event.

• Brand Name: LIFEPAK(R) 20 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: 8733105
• Report Number: 0003015876-2019-01095
• Device Sequence Number: 11406278
• Product Code: MKJ
• UDI-Device Identifier: 00883873813782
• UDI-Public: 00883873813782
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• 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
• Report Date (Section B): 06/25/2019

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: 20
• Device Catalogue Number: 99402-000067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 06/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1