BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LUCAS ® CPR CHEST COMPRESSION SYSTEM

    MDR report key: 16162525 · Received January 13, 2023

    Report

    Report Number
    0003015876-2023-00067
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    January 8, 2021
    Report Date
    January 13, 2023
    Manufacturer
    JOLIFE AB - 3005445717
    Product Code
    DRM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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 # 0003015876-2021-01729. PHYSIO-CONTROL CONTACTED THE CUSTOMER TO REQUEST ADDITIONAL INFORMATION ON THE PATIENT AND DEVICE. NO RESPONSE HAS BEEN RECEIVED FROM THE CUSTOMER. PATIENT AND DEVICE FIELDS IN WHICH INFORMATION IS NOT PROVIDED WERE INTENTIONALLY LEFT BLANK. THE DEVICE WAS NOT RETURNED TO PHYSIO-CONTROL FOR EVALUATION. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE CUSTOMER CONTACTED PHYSIO-CONTROL TO REPORT THAT AFTER USING THEIR DEVICE THE PATIENT WAS FOUND TO HAVE A T9/T10 THORACIC SPINE FRACTURE. THERE WAS PATIENT INVOLVEMENT IN THIS EVENT AND THE DEVICE USE MAY HAVE CONTRIBUTED TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963857 LUCAS ® CPR CHEST COMPRESSION SYSTEM COMPRESSOR, CARDIAC, EXTERNAL DRM JOLIFE AB - 3005445717 LUCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other