BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFELINE

    MDR report key: 18918500 · Received March 15, 2024

    Report

    Report Number
    3003521780-2024-00169
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 14, 2024
    Manufacturer
    DEFIBTECH, L.L.C.
    Product Code
    DRM
    UDI-DI
    10815098020536
    PMA / PMN Number
    K141809
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH REQUESTED, THE DEVICE ASSOCIATED WITH THE EVENT 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: HEAVY DAMAGE TO CASING, LIKELY DUE TO BEING DROPPED OR PHYSICALLY DAMAGED IN SOME MANNER. THERE IS A HOLE PUNCHED THROUGH THE FRONT CASE HALF, AND LOOSE PLASTIC CAN BE HEARD INSIDE THE UNIT, LIKELY FROM A BROKEN BOSS INSIDE THE CASE HALVES. BOTH HALVES ARE SEPARATING AT THE SEAM. THE SN LABEL IS DAMAGED BUT SCANNABLE. ELECTRIC/MECHANICAL TEST: THE UNIT PERFORMED AS EXPECTED, SUCCESSFULLY COMPLETING COMPRESSIONS. INTERNAL VISUAL INSPECTION: ALL COMPONENTS APPEAR TO BE IN GOOD CONDITION. RECORD TROUBLESHOOTING STEPS: REPLACED FRONT CASE HALF, UI, TWO SHORT SLEEVES, AND THE SN LABEL. THE UNIT IS PERFORMING COMPRESSIONS. BALL SCREW AND BEARING GUIDE INSPECTION: THE BALL SCREW AND BEARING GUIDE ARE IN GOOD CONDITION. THE BALL SCREW WAS INSPECTED AND RE-GREASED. FINAL INTERNAL VISUAL INSPECTION: ALL COMPONENTS ARE IN GOOD CONDITION. PREVENTIVE MAINTENANCE WAS PERFORMED. FINAL REPAIR COMMENTS: THE UNIT IS IN GOOD SHAPE AND PERFORMING AS EXPECTED. SERVICE ASSEMBLY: PASSED. SYSTEM FUNCTIONAL TEST: PASSED. BURN-IN: PASSED. FINAL EXTERNAL VISUAL INSPECTION: THE UNIT PERFORMED AS EXPECTED AND IS IN GOOD CONDITION. FQA: PASSED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED THE ARM'S HOUSING CRACKED DURING A RESCUE ATTEMPT. THEY FURTHER REPORTED THAT THE CRACKED HOUSING DID NOT AFFECT THE OUTCOME OF THE RESCUE. NO PATIENT INFORMATION WAS PROVIDED OTHER THAN THE PATIENT SURVIVED TO HOSPITAL BUT DID NOT SURVIVE TO HOSPITAL DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535503 LIFELINE AUTOMATED CHEST COMPRESSOR DRM DEFIBTECH, L.L.C. RMU-1000 10815098020536

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown