BEUDAMED
    FDA Adverse Event Death Summary report: N

    LUCAS (T) CPR CHEST COMPRESSION SYSTEM

    MDR report key: 3924769 · Received July 1, 2014

    Report

    Report Number
    3005445717-2014-00003
    Event Type
    Death
    Date Received
    July 1, 2014
    Date of Event
    January 8, 2013
    Report Date
    June 24, 2014
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) AN IMPORTER /DISTRIBUTOR FOR JOLIFE (B)(4), PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT THE DEVICE USE COULD HAVE CONTRIBUTED TO THE DEATH OF THE PATIENT. THE PATIENT HAD A LOT OF AIR IN THE STOMACH LIKELY DUE TO THE WRONG POSITION OF THE ENDOTRACHEAL TUBE PLACED IN THE ESOPHAGUS INSTEAD OF THE TRACHEA. THE USE OF THE DEVICE ON THE PATIENT WITH THE AIR IN THE PATIENT'S STOMACH COULD HAVE CAUSED THE RUPTURE OF THE STOMACH. THE DEVICE WAS NOT RETURNED TO (B)(4) FOR EVALUATION. THIS ISSUE WAS ATTRIBUTED TO USE ERROR AND THERE WAS NO INDICATION OF A FAILURE OF THE DEVICE. THIS REPORT HAS BEEN PREVIOUSLY REPORTED BY (B)(4) UNDER MANUFACTURER REPORT # 3015876-2013-00505.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A PIECE OF LITERATURE IN ASSOCIATION WITH MANUAL CPR THAT THE DEVICE WAS USED ON A PATIENT WHO WAS RECEIVING CPR OUTSIDE THE HOSPITAL AND HAD BEEN VENTILATED. DURING THE INTUBATION IT HAD BEEN VERY DIFFICULT TO GET THE TUBE IN SITU. ON THE ER THE PATIENT HAD OUTPUT AND THE LUCAS WAS REMOVED. THE PATIENT DID NOT FEEL WELL AND WAS DIAGNOSED WITH A STOMACH RUPTURE (BLOWOUT FROM THE STOMACH) AND WAS OPERATED ON SEVERAL TIMES. THE PATIENT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381597 LUCAS (T) CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death