BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS (T) CPR CHEST COMPRESSION SYSTEM

    MDR report key: 3926100 · Received July 1, 2014

    Report

    Report Number
    3005445717-2014-00004
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 20, 2013
    Report Date
    June 27, 2014
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), EVALUATED THE DEVICE BUT COULD NOT OBSERVE ANY MALFUNCTIONS OF THE DEVICE. PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING AND AFTER UNRELATED REPAIRS WERE PERFORMED, THE DEVICE WAS RETURNED TO THE CUSTOMER FOR USE. THE CUSTOMER REPORTED THAT THEIR INVESTIGATION OF THE ISSUE HAS CONCLUDED THAT THE LIKELY CAUSE OF THE LACERATION TO THE PATIENT WAS DUE TO A FAILURE TO USE THE DEVICE STABILIZATION STRAP (BECAUSE IT WAS MISSING) IN CONJUNCTION WITH THE DEVICE NOT BEING PAUSED AS THE PATIENT WAS BEING MOVED ONTO THE "SCOOP" WHICH LEAD TO THE DEVICE SLIPPING OFF THE PATIENT'S CHEST (STERNUM) AND CAUSING THE TEARING LACERATION. REPLACEMENT STABILIZATION STRAPS HAVE BEEN PROVIDED TO THE CUSTOMER. ADDITIONAL TRAINING REGARDING DEVICE USE HAS ALSO BEEN OFFERED. PHYSIO-CONTROL PERFORMED A CLINICAL REVIEW OF THE REPORTED EVENT AND DETERMINED THAT USE ERROR OF THE DEVICE LIKELY CAUSED THE INJURY OF THE PATIENT. THIS REPORT HAS BEEN PREVIOUSLY REPORTED BY PHYSIO-CONTROL, INC. UNDER MANUFACTURER REPORT# 3015876-2013-00511.

    Description of Event or Problem · 1

    IT WAS REPORTED TO A PHYSIO-CONTROL BUSINESS DEVELOPMENT MANAGER THAT A PATIENT HAD A PUNCTURE WOUND IN THE CHEST FOLLOWING THE USE OF A DEVICE FOR AUTOMATED CPR. THE PATIENT WAS A (B)(6). THE PATIENT'S TISSUE WAS EXPOSED AND THE STERNUM WAS VISIBLE. THE PATIENT WAS FOUND IN PULSELESS ELECTRICAL ACTIVITY (PEA) CARDIAC ARREST ON THE ARRIVAL OF THE AMBULANCE CREW. THE CREW THEN APPLIED THE DEVICE FOR AUTOMATED CPR ON THE PATIENT. THE DEVICE'S SUCTION CUP WAS ATTACHED DURING THE ENTIRE EVENT, IT DID NOT COME OFF AND IT WAS INTACT AFTER THE EVENT. THE DEVICE'S STABILIZATION STRAPS WERE NOT USED, AS THEY WERE MISSING. THE WOUND WAS DISCOVERED WHEN THE PATIENT WAS MOVED TO THE AMBULANCE. THE CREW THEN STARTED MANUAL CPR. THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381886 LUCAS (T) CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Disability