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	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not returned to physio-control.A third-party service agent performed an initial evaluation of the customer's device and verified the reported issue.Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803.56.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that their device had illuminated its service led and would not complete its boot-up cycle.In this state, the device would not be able to provide therapy, if it were needed.
Additional Manufacturer Narrative
The customer declined advised repairs to their device.The device was returned to the customer without repair.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted physio-control to report that their device had illuminated its service led and would not complete its boot-up cycle.In this state, the device would not be able to provide therapy, if it were needed.

• 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: 8641515
• Report Number: 0003015876-2019-00913
• Device Sequence Number: 2446173
• Product Code: MKJ
• UDI-Device Identifier: 00883873813737
• UDI-Public: 00883873813737
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K130454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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: 99402-000001
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1