BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM

    MDR report key: 6052748 · Received October 24, 2016

    Report

    Report Number
    3015876-2016-01278
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 26, 2016
    Report Date
    October 24, 2016
    Manufacturer
    JOLIFE AB
    Product Code
    DRM
    PMA / PMN Number
    K090422
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    E2014029. (B)(4). PHYSIO-CONTROL COMPLETED A CLINICAL EVALUATION OF THE REPORTED EVENT AND CONCLUDED THAT DUE TO THE LIMITED INFORMATION AVAILABLE, IT WAS NOT POSSIBLE TO DETERMINE IF THE VERTEBRAE FRACTURE WAS RELATED TO THE CHEST COMPRESSIONS, DEFIBRILLATION OR WAS A SECONDARY COMPLICATION FROM CARDIAC ARREST. IT COULD NOT BE EXCLUDED THAT THE MECHANICAL CHEST COMPRESSIONS FROM THE DEVICE MAY HAVE CONTRIBUTED TO THE REPORTED VERTEBRAE FRACTURE. PHYSIO-CONTROL HAS MADE MULTIPLE UNSUCCESSFUL ATTEMPTS TO CONTACT THE AUTHOR OF THE PUBLISHED ARTICLE IN ORDER TO GATHER ADDITIONAL DETAILS REGARDING THE REPORTED EVENT. TO DATE, THE AUTHOR HAS NOT RESPONDED TO THESE REQUESTS. THE DEVICE HAS NOT BEEN RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THIS FOLLOWING INFORMATION WAS FOUND DURING AN ONLINE LITERATURE SEARCH. REFERENCE "MARSHALL RT, KOTECHA H, CHIBA T, TENNYSON J. THORACIC SPINE FRACTURE IN A SURVIVOR OF OUT-OF-HOSPITAL CARDIAC ARREST WITH MECHANICAL CPR. PREHOSP DISASTER MED. 2016;31(6):1-3." "THIS IS A REPORT OF A THORACIC VERTEBRAL FRACTURE IN A (B)(6) MALE SURVIVOR OF OUT-OF-HOSPITAL CARDIAC ARREST WITH CHEST COMPRESSIONS PROVIDED BY A LUCAS 2 (PHYSIO-CONTROL INC.; (B)(4)) DEVICE. THIS IS THE FIRST SUCH REPORT IN THE LITERATURE OF A VERTEBRAL FRACTURE BEING NOTED IN A SURVIVOR OF CARDIAC ARREST WHERE AN AUTOMATED COMPRESSION DEVICE WAS USED." NEITHER THE SERIAL NUMBER OF THE DEVICE, NOR THE ACTUAL DATE OF THE EVENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701867 LUCAS¿ 2 CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB LUCAS 2

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention