BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS¿ CPR CHEST COMPRESSION SYSTEM

    MDR report key: 16315528 · Received February 7, 2023

    Report

    Report Number
    3005445717-2023-00038
    Event Type
    Death
    Date Received
    February 7, 2023
    Date of Event
    December 22, 2022
    Report Date
    May 4, 2023
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K173553
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    STRYKER RECEIVED ADDITIONAL PATIENT INFORMATION FROM THE CUSTOMER. 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. AS DESCRIBED, RIB FRACTURES AND INJURIES TO THE LIVER OCCUR WITH BOTH MANUAL AND MECHANICAL CPR. WITH THE LIMITED DATA PROVIDED IN THIS CASE, IT CANNOT BE EXCLUDED THAT LUCAS COMPRESSIONS CAUSED RIB FRACTURES AND LIVER INJURY.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED TO STRYKER FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE USE RESULTED IN THE PATIENT BEING INJURED WITH RIBS FRACTURE AND LIVER DAMAGE. THE INVOLVED PATIENT ULTIMATELY DID NOT SURVIVE.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED STRYKER TO REPORT THAT THEIR DEVICE USE RESULTED IN THE PATIENT BEING INJURED WITH RIBS FRACTURE AND LIVER DAMAGE. THE INVOLVED PATIENT ULTIMATELY DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2230244 LUCAS¿ CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL / DRM DRM JOLIFE AB - 3005445717 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death