MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 500 AUTOMATED EXTERNAL DEFIBRILLATOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Catalog Number	97401-000011
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control advised the customer that their device is no longer supported by physio-control and that, as a result, parts and service are not available.Physio-control recommended that the device be permanently removed from service and that a replacement unit be obtained.The device has not been 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 that their monophasic device had a service wrench present on its readiness display.Additionally, an event code had been logged in the device's memory which indicated that it would not likely be able to provided defibrillation therapy if it were necessary.There was no patient use associated with the reported event.

• Brand Name: LIFEPAK(R) 500 AUTOMATED EXTERNAL 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: 8493496
• Report Number: 0003015876-2019-00610
• Device Sequence Number: 1761703
• Product Code: MKJ
• UDI-Device Identifier: 00721902143199
• UDI-Public: 00721902143199
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K052057
• 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): 04/08/2019

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: Lay User/Patient
• Device Catalogue Number: 97401-000011
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1