BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS 2, 2.2, IN SHIPPING BOX,EN,DA,SV,FI,NO

    MDR report key: 16244025 · Received January 25, 2023

    Report

    Report Number
    0003015876-2023-00137
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    March 1, 2020
    Report Date
    January 25, 2023
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FI
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED TO CORRECT THE INCORRECT MANUFACTURING SITE AND RELATED FIELDS THAT WERE PREVIOUSLY SUBMITTED UNDER MFR 3005445717-2020-00004. PHYSIO-CONTROL PERFORMED AN CLINICAL REVIEW AND DETERMINED THAT BASED ON THE AVAILABLE INFORMATION, THE DEVICE USE MAY HAVE CONTRIBUTED TO THE PATIENT OUTCOME. IT CAN NOT BE EXCLUDED THAT THE LIVER LACERATIONS OCCUR WHEN PROVIDING CHEST COMPRESSIONS DURING BOTH MANUAL AND MECHANICAL CPR. RIB FRACTURES AND OTHER INJURIES ARE COMMON BUT ACCEPTABLE CONSEQUENCES OF CPR GIVEN THE ALTERNATIVE OF DEATH FROM CARDIAC ARREST. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT THEIR DEVICE HAD POTENTIALLY CAUSED LIVER LACERATION, A BROKEN RIB, AND REFRACTORY BLEEDING, DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1026203 LUCAS 2, 2.2, IN SHIPPING BOX,EN,DA,SV,FI,NO COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB - 3005445717 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Hospitalization