BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS¿ CPR CHEST COMPRESSION SYSTEM

    MDR report key: 20789979 · Received November 27, 2024

    Report

    Report Number
    3005445717-2024-00018
    Event Type
    Death
    Date Received
    November 27, 2024
    Date of Event
    November 1, 2024
    Report Date
    May 12, 2025
    Manufacturer
    PHYSIO-CONTROL, INC. - 3015876
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. STRYKER CONTACTED THE CUSTOMER, TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT. STRYKER REQUESTS, PATIENT INFORMATION NECESSARY FOR REGULATORY COMPLIANCE, STRICTLY ADHERING TO HIPAA'S PRIVACY RULE. 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 OF THE REPORTED EVENT AND DETERMINED, THAT THERE WAS INSUFFICIENT INFORMATION PROVIDED, THAT THE DEVICE DID NOT CONTRIBUTE TO THE PATIENT OUTCOME.

    Additional Manufacturer Narrative · 0

    A STRYKER FIELD SERVICE REPRESENTATIVE (FSR) VERIFIED AND DUPLICATED THE REPORTED ISSUE. THE ROOT CAUSE OF THE REPORTED ISSUE WAS TRACED TO A DAMAGED ANGLE SHAFT ON THE SUPPORT LEG WHICH RESULTED IN THE SUPPORT LEG OVEREXTENDING THE BACKPLATE. COMMUNICATIONS WITH THE CUSTOMER INDICATED THAT CPR WAS DELAYED BY APPROXIMATELY 2 MINUTES BEFORE THE LUCAS DEVICE WAS SUCCESSFULLY LOCKED TO THE BACKPLATE. THE CUSTOMER DECLINED THE REPAIR OF THE LUCAS 2 DEVICE AND RECEIVED A REPLACEMENT. A CLINICAL REVIEW WAS PERFORMED AND IT WAS DETERMINED THAT THE DEVICE USE MAY HAVE CONTRIBUTED TO THE REPORTED ADVERSE OUTCOME.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER, TO REPORT THAT THEIR LUCAS DEVICE WAS NOT LATCHING ONTO THE BACK OF THE COMPRESSION BOARD. THE CUSTOMER WAS UNABLE TO USE THE DEVICE. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR LUCAS DEVICE WAS NOT LATCHING ONTO THE BACK OF THE COMPRESSION BOARD. THE CUSTOMER WAS UNABLE TO USE THE DEVICE. THE PATIENT INVOLVED IN THE REPORTED EVENT IS DECEASED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357347 LUCAS¿ CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM PHYSIO-CONTROL, INC. - 3015876 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Death