BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS CPR CHEST COMPRESSION SYSTEM

    MDR report key: 4360724 · Received December 17, 2014

    Report

    Report Number
    3015876-2014-01505
    Event Type
    Death
    Date Received
    December 17, 2014
    Date of Event
    November 5, 2014
    Report Date
    November 18, 2014
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE REPORTED INFO, THERE WAS NO INDICATION OF A DEVICE MALFUNCTION OR USE ERROR ASSOCIATED WITH THE REPORTED EVENT. THE CUSTOMER CONTINUES TO USE THE DEVICE. A CLINICAL REVIEW OF THE REPORTED ISSUE WAS PERFORMED BY JOLIFE AND PHYSIO-CONTROL WITH THE FOLLOWING CONCLUSIONS: INJURIES AT THE HEART AND GREAT VESSELS OCCUR IN ABOUT 11% OF THE CASES DURING MANUAL CPR (REFERENCE: CARDIAC ARREST, THE SCIENCE AND PRACTICE OF RESUSCITATION MEDICINE. PARADIS, HALPERIN PAGE 576). BASED ON THE LIMITED INFO PROVIDED BY THE HOSPITAL ASSOCIATE PROFESSOR REGARDING THE INJURY AT THE PERICARDIUM AND INFO FROM THE HOSPITAL FORENSIC DEPARTMENT WHICH COULD NEITHER CONFIRM OR EXCLUDE THAT THE DAMAGE WAS CAUSED BY LUCAS, IT MAY NOT BE EXCLUDED THAT THE USE OF LUCAS CONTRIBUTED TO THE PT'S OUTCOME. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL TO JOLIFE FOR EVAL. PHYSIO-CONTROL IS SUBMITTING THIS MEDWATCH REPORT ON BEHALF OF JOLIFE AB (MFR). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY RESPONDED TO A CARDIAC ARREST. THEIR LUCAS CPR CHEST COMPRESSION DEVICE (LUCAS) WAS CONNECTED TO THE PT DURING TRANSPORT IN A HELICOPTER FOR APPROX 40 MINUTES. ONCE THE PT ARRIVED AT THE HOSPITAL, THE LUCAS WAS REMOVED AND MANUAL CPR WAS CONTINUED. THE PT NEVER REGAINED CARDIAC ACTIVITY AND DID NOT SURVIVE. IT WAS LATER CONFIRMED THAT AN INJURY TO THE PT'S PERICARDIUM HAD OCCURRED. THERE WERE ALSO MULTIPLE RIB FRACTURES AND HEMOTHORAX NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826555 LUCAS CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death