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

Catalog Number	99401-000618
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 returned for evaluation.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on.In this state the device would not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Event or Problem Description
The customer contacted physio-control to report that their device would not power on.In this state the device would not be able to deliver defibrillation therapy if needed.There was no report of patient use associated with the reported event.
Additional Manufacturer Narrative
The device has not been returned to physio-control for evaluation.The customer confirmed that the device was removed from service and would not be returned.The reported issue could not be verified and the cause of the reported issue could not be determined.

• 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: 9555601
• Report Number: 0003015876-2020-00029
• Device Sequence Number: 3403535
• Product Code: MKJ
• UDI-Device Identifier: 00721902549540
• UDI-Public: 00721902549540
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K052057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2020

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 Catalogue Number: 99401-000618
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 03/26/2020
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1