MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK® 20E DEFIBRILLATOR/MONITOR; AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

Model Number	20E
Medical Device Problem Code	Failure to Charge (1085)
Health Effect - Clinical Code	Chest Pain (1776)
Date of Event	09/05/2022
Type of Reportable Event	Death
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 performed a clinical review of the reported event and determined that the device use may have contributed to the patient's outcome as the patient presented with a shockable rhythm, but defibrillation therapy was delayed.Stryker continues to investigate the reported failure 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 they were using their device during a patient event and the attempted to charge the device to deliver defibrillation therapy; however, the device failed to charge.The users attempted to charge the device again and this time it worked and they were able to deliver multiple shocks to the patient.The patient involved in the reported event is deceased.
Event or Problem Description
The customer contacted stryker to report that they were using their device during a patient event and the attempted to charge the device to deliver defibrillation therapy; however, the device failed to charge.The users attempted to charge the device again and this time it worked and they were able to deliver multiple shocks to the patient.The patient involved in the reported event is deceased.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to duplicate the reported issue.Stryker downloaded the device's electronic records from the event for review and was able to verify the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The cause of the reported issue could not be determined.

• Brand Name: LIFEPAK® 20E DEFIBRILLATOR/MONITOR
• 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: 15543667
• Report Number: 0003015876-2022-02207
• Device Sequence Number: 6511768
• Product Code: MKJ
• UDI-Device Identifier: 00883873853863
• UDI-Public: 00883873853863
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K130454
• 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): 02/01/2023

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: 20E
• Device Catalogue Number: 99507-000122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2017
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White