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

Model Number	20E
Medical Device Problem Codes	Failure to Charge (1085); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/13/2024
Type of Reportable Event	Death
Event or Problem Description
The customer contacted stryker to report that their device failed to charge.In this state the device would be inoperable and defibrillation therapy would not be available if needed.The patient associated with the reported event did not survive.
Additional Manufacturer Narrative
Stryker performed an initial evaluation of the customer¿s device and was unable to verify and unable to duplicate the reported issue.Proper device operation was observed through functional and performance testing.The device was subsequently returned to the customer.Stryker contacted the customer to request additional information on the patient.No response has been received from the customer.Patient fields in which information is not provided were intentionally left blank.Stryker performed a clinical review regarding the reported issue.A review of the device data indicates that at device time 03:40:16pm to 03:40:25pm, the patient presented with a shockable rhythm; however, defibrillation was not provided.In the medical judgment of these reviewers, it is reasonable to conclude the device use may have contributed to the patient¿s outcome.

• Brand Name: LIFEPAK(R) 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: brian blakeslee ; 11811 willows road ne; redmond, WA 98052 ; 4258674000
• MDR Report Key: 18659228
• Report Number: 0003015876-2024-00289
• Device Sequence Number: 6885337
• Product Code: MKJ
• UDI-Device Identifier: 00883873852798
• UDI-Public: 00883873852798
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 02/07/2024

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: 99507-000133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2017
• 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: 45 YR
• Patient Sex: Male