BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIFEPAK® 15 DEFIBRILLATOR/MONITOR

    MDR report key: 14981986 · Received July 11, 2022

    Report

    Report Number
    0003015876-2022-01434
    Event Type
    Death
    Date Received
    July 11, 2022
    Date of Event
    June 15, 2022
    Report Date
    July 11, 2022
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    MKJ
    UDI-DI
    00883873871713
    PMA / PMN Number
    K142430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER EVALUATED THE CUSTOMER'S DEVICE AND UNDER ABLE TO VERIFY AND DUPLICATE THE REPORTED ISSUE. FURTHER COMMUNICATION, THE CUSTOMER ACKNOWLEDGES THAT THE DEVICE DID NOT MANUALLY CHANGE TO PADDLE MODE FOR ECG TO BE DISPLAYED. AFTER OBSERVING PROPER DEVICE OPERATION THROUGH FUNCTIONAL AND PERFORMANCE TESTING, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. STRYKER CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. THE CUSTOMER PROVIDED STRYKER WITH THE AVAILABLE PATIENT INFORMATION. PATIENT FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. STRYKER PERFORMED A CLINICAL REVIEW REGARDING THE REPORTED ISSUE. THERE IS NO DEVICE DATA OR SUFFICIENT REPORTED INFORMATION TO DETERMINE DEVICE CONTRIBUTION TO THE REPORTED OUTCOME. IN THE MEDICAL JUDGMENT OF THESE REVIEWERS, IT IS UNKNOWN IF THE DEVICE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY OR DEATH.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE DID NOT RECOGNIZE THE PADS AND NO ECG WAS DISPLAYED. IN THIS STATE, THE DEVICE MAY NOT BE ABLE TO DELIVER DEFIBRILLATION THERAPY. THE PATIENT ASSOCIATED WITH THE REPORTED EVENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2058873 LIFEPAK® 15 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ PHYSIO-CONTROL, INC. - 3015876 15 00883873871713

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Death