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

Model Number	15
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Unexpected Shutdown (4019)
Health Effect - Clinical Codes	Bradycardia (1751); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2022
Type of Reportable Event	Malfunction
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.Stryker 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 stryker to report that their device powered off by itself when performed cardioversion on a patient.A different defibrillator was used to complete the procedure.In addition it was reported the device logged a critical event code.The event code is related to a potential issue of the device to deliver energy.In this state, defibrillation therapy may be delayed or not available if needed.This issue is patient related; however, there was no adverse patient outcome reported.
Additional Manufacturer Narrative
Stryker evaluated the customer¿s device and was unable to duplicate or verify the reported issue power issue.The reported event code issue was verified, however the code was not repeatable.After observing proper device operation through functional and performance testing the device was returned to the customer for use.The cause of the reported issues could not be conclusively determined.
Event or Problem Description
The customer contacted stryker to report that their device powered off by itself when performed cardioversion on a patient.A different defibrillator was used to complete the procedure.In addition it was reported the device logged a critical event code.The event code is related to a potential issue of the device to deliver energy.In this state, defibrillation therapy may be delayed or not available if needed.This issue is patient related; however, there was no adverse patient outcome reported.

• Brand Name: LIFEPAK(R) 15 MONITOR/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: 16011035
• Report Number: 0003015876-2022-02727
• Device Sequence Number: 7303505
• Product Code: MKJ
• UDI-Device Identifier: 00883873871676
• UDI-Public: 00883873871676
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160026
• 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): 03/07/2023

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 Model Number: 15
• Device Catalogue Number: 99577-001959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/07/2022
• Supplement Date Received by Manufacturer: 03/06/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2021
• 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 Sex: Unknown