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

Model Number	15
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	12/12/2023
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 it is unknown if the device use contributed to the patient outcome for the following reason: insufficient data within the file to determine the impact of the device use.The electrodes and patient¿s electronic data (pco) were unavailable for analysis.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 during a patient event their device was unable to detect the patient through the defibrillation electrodes.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.The crew unplugged the cables from the device and the defibrillation electrodes and reconnected them.The defibrillation electrodes were replaced.However, the issue remained.The cables were switched with another device to treat the patient.The patient was pronounced dead at the hospital after ongoing resuscitation at the emergency department.
Additional Manufacturer Narrative
Stryker evaluated the customer's device and was unable to verify or duplicate the reported issue.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.A review of the electronic records of the device indicated the device was working normally.The cause of the reported issue could not be determined.
Event or Problem Description
The customer contacted stryker to report that during a patient event their device was unable to detect the patient through the defibrillation electrodes.In this state, defibrillation therapy may be delayed or prevented from being delivered to the patient if needed.The customer advised that the device prompted them to ¿connect electrodes¿ when the defibrillation electrodes were connected to the patient.The crew unplugged the cables from the device and the defibrillation electrodes and reconnected them.The defibrillation electrodes were replaced.However, the issue remained.The cables were switched with another device to treat the patient.The patient was pronounced dead at the hospital after ongoing resuscitation at the emergency department.

• 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
• 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: 18364846
• Report Number: 0003015876-2023-02427
• Device Sequence Number: 7912690
• Product Code: MKJ
• UDI-Device Identifier: 00883873884331
• UDI-Public: 00883873884331
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 05/08/2024

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: 15
• Device Catalogue Number: 99577-001373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White