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

Model Number	20E
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Power Problem (3010)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This was reported from an international facility.The device was not returned to physio-control for evaluation.The cause of the reported issue could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report their device was intermittently power cycling.There was no patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report their device was intermittently power cycling.There was no patient use associated with the reported event.
Additional Manufacturer Narrative
Physio-control received additional device information from the customer.The device serial number is (b)(4).Fields h4, d4 and d10 have been updated.
Additional Manufacturer Narrative
A third party service agent evaluated the customer¿s device.The service agent replaced the device¿s therapy pcb assembly.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 their device was intermittently power cycling.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK® 20E 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: 8843663
• Report Number: 0003015876-2019-01285
• Device Sequence Number: 1606891
• Product Code: MKJ
• UDI-Device Identifier: 00883873813751
• UDI-Public: 00883873813751
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K130454
• 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,Followup
• Report Date (Section B): 05/29/2020

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: 20E
• Device Catalogue Number: 99507-000001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 10/25/2019; 05/20/2020
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 10/29/2019; 05/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1