MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK 15 DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS NON-WEARABLE

Model Number	15
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	Death (1802)
Date of Event	05/23/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The customer was unable to provide any further information for the event or the patient.Physio-control performed an initial evaluation of the customer's device and verified the reported issue.A replacement device will be provided to the customer.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.
Event or Problem Description
The customer contacted physio-control to report that their device would turn off after shocking the patient and needed to be turned back on.In this state the device may not be able to deliver defibrillation therapy if needed.The customer reported that the patient expired.They reported that there was some delay before the paramedic noticed the monitor screen was black.The customer alleged that there could have been a change of rhythm that could have been missed while the monitor was shut down.
Event or Problem Description
The customer contacted physio-control to report that their device would turn off after shocking the patient and needed to be turned back on.In this state the device may not be able to deliver defibrillation therapy if needed.The customer reported that the patient expired.They reported that there was some delay before the paramedic noticed the monitor screen was black.The customer alleged that there could have been a change of rhythm that could have been missed while the monitor was shut down.
Additional Manufacturer Narrative
A clinical review was completed and determined that, "device use may have contributed" to the reported issue.It stated, "defibrillation needed (by ecg evidence or report of 2nd responders) but provision of defibrillation delayed greater than 30 seconds.The device powered off at 11:18:44 and when powered back on at 11:21:24 the patient was in a shockable rhythm with ventricular fibrillation on the monitor.".
Event or Problem Description
The customer contacted physio-control to report that their device would turn off after shocking the patient and needed to be turned back on.In this state the device may not be able to deliver defibrillation therapy if needed.The customer reported that the patient expired.They reported that there was some delay before the paramedic noticed the monitor screen was black.The customer alleged that there could have been a change of rhythm that could have been missed while the monitor was shut down.
Additional Manufacturer Narrative
The electronic device records were reviewed and the reported issue was confirmed.It was determined that the power board and battery wire harness need to be replaced.However, because the device is eleven years old, stryker no longer provides the required replacement parts.The customer was notified that the device is outside the service life and the device should be replaced.

• Brand Name: LIFEPAK 15 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: 10179247
• Report Number: 0003015876-2020-00783
• Device Sequence Number: 2438589
• Product Code: MKJ
• UDI-Device Identifier: 00883873979358
• UDI-Public: 00883873979358
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K142430
• 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,Followup
• Report Date (Section B): 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15
• Device Catalogue Number: 99577-000061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/28/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 09/08/2020
• Initial Report FDA Received Date: 06/22/2020
• Supplement Report FDA Received Date: 07/08/2020; 09/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 76 YR
• Patient Weight: 100