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

Catalog Number	99401-001083
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	07/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted stryker to report that their device would not power on during a patient event.When the device did not power on, cpr was continued.A back up device was retrieved and was able to provide therapy to the patient.The customer advised that the patient was successfully resuscitated.
Additional Manufacturer Narrative
The customer provided stryker with all the available patient information.Patient fields in which information was not provided were intentionally left blank.The device was not returned to stryker for evaluation.The cause of the reported issue could not be determined.
Additional Manufacturer Narrative
The device was removed from service and was scrapped by the customer.
Event or Problem Description
The customer contacted stryker to report that their device would not power on during a patient event.When the device did not power on, cpr was continued.A back up device was retrieved and was able to provide therapy to the patient.The customer advised that the patient was successfully resuscitated.

• 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
• Manufacturer (Section G): PHYSIO-CONTROL, INC. - 3015876; 11811 willows road ne; redmond WA 98052
• Manufacturer Contact: todd bandy ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 15169090
• Report Number: 0003015876-2022-01773
• Device Sequence Number: 6330287
• Product Code: MKJ
• UDI-Device Identifier: 00885074753973
• UDI-Public: 00885074753973
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2022

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: 99401-001083
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2006
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White