BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 18542648 · Received January 19, 2024

    Report

    Report Number
    3003521780-2023-00316
    Event Type
    Malfunction
    Date Received
    January 19, 2024
    Date of Event
    December 23, 2023
    Report Date
    December 26, 2023
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    DRM
    UDI-DI
    10815098020536
    PMA / PMN Number
    K141809
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH REQUESTED, THE DEVICE ASSOCIATED WITH THIS COMPLAINT HAS NOT BEEN RETURNED AND THE CAUSE OF THE COMPLAINT IS NOT KNOWN. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP MDR SHALL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    EXTERNAL VISUAL INSPECTION: UNIT IS IN GOOD CONDITION; NO DAMAGE NOTED. SN LABEL IS UNDAMAGED. ELECTRIC/MECHANICAL TEST: UNIT FAILED HOME ASSESS BUT OTHERWISE PERFORMED COMPRESSIONS AS EXPECTED. PISTON DID NOT RETRACT ON POWER OFF. INCOMING INSPECTION: FAILED. INTERNAL VISUAL INSPECTION: ALL COMPONENTS APPEAR TO BE IN GOOD CONDITION. RECORD TROUBLESHOOTING STEPS: SWAPPED OUT MOTOR FOR TEST MOTOR, AND IT DELIVERED COMPRESSIONS NORMALLY. COULD NOT REPLICATE THE ISSUE AFTER RE-GREASING AND REASSEMBLY. TESTED POWER ON/DELIVERING COMPRESSIONS AND POWER OFF MORE THAN A DOZEN TIMES, AND THE UNIT PERFORMED AS EXPECTED. FINAL INTERNAL VISUAL INSPECTION: ALL COMPONENTS ARE IN GOOD CONDITION. PREVENTIVE MAINTENANCE WAS PERFORMED. FINAL REPAIR COMMENTS: UNIT IS IN GOOD SHAPE AND PERFORMING AS EXPECTED. SERVICE ASSEMBLY: PASSED. SYSTEM FUNCTIONAL TEST: PASSED. BURN-IN: PASSED. SERVICE ASSEMBLY: REPAIR. INTERNAL VISUAL INSPECTION: ALL COMPONENTS APPEAR TO BE IN GOOD CONDITION. RECORD TROUBLESHOOTING STEPS: DOWNLOADED HISTORY AFTER FAILURE; DID NOT SEE ANYTHING UNUSUAL. OPENED UP THE UNIT, AND EVERYTHING LOOKS TO BE IN GOOD SHAPE. SERVICE ASSEMBLY: PASSED. SYSTEM FUNCTIONAL TEST: PASSED. BURN-IN: PASSED. EXTERNAL VISUAL INSPECTION: USB CONNECTION ERROR OCCURRED MID-TEST. FQA: FAILED. RMC: OPEN - FAIL OPEN COMM - UNIT FAILED. RMU: ERR - UNKNOWN RMU ENCOUNTERED AN UNKNOWN DEVICE ERROR. EXTERNAL VISUAL INSPECTION: UNIT PERFORMED AS EXPECTED AND IS IN GOOD CONDITION. FQA: PASSED. FINAL COMMENTS: CANNOT REPLICATE ISSUE CONSISTENTLY OR DETERMINE THE ROOT CAUSE. ARM SHOULD BE REMOVED FROM SERVICE.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THAT WHILE RUNNING A CODE, THE RMU-1000 CEASED PERFORMING COMPRESSIONS, FOLLOWED BY THE WARNING AND MAINTENANCE LIGHTS GOING OFF AND BEEPING. THEY ATTEMPTED TO TROUBLESHOOT ON SCENE BUT RESORTED TO MANUAL COMPRESSIONS. THE PATIENT WAS NOT RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478626 LIFELINE AUTOMATED CHEST COMPRESSOR DRM DEFIBTECH, L.L.C. RMU-1000 10815098020536

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death