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

Catalog Number	99401-000210
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Physio-control advised the customer that there is no service repair available or repair parts for their device and it is no longer under warranty.Physio recommended that the customer remove the device from service and a replacement device be obtained.The device has not been returned to physio-control for an evaluation.The cause of the reported event could not be determined.Device not evaluated by manufacturer.
Event or Problem Description
The customer contacted physio-control to report that the service indicator on their device is flashing and a call service message is displayed.The device also logged an event code that is related to a potential failure of the device to deliver defibrillation energy.There was no patient use associated with the reported event.

• Brand Name: BIPHASIC LIFEPAK® 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: 8382920
• Report Number: 0003015876-2019-00354
• Device Sequence Number: 11207845
• Product Code: MKJ
• UDI-Device Identifier: 00721902172557
• UDI-Public: 00721902172557
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K052057
• 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
• Report Date (Section B): 03/01/2019

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 Catalogue Number: 99401-000210
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1