BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 18971432 · Received March 25, 2024

    Report

    Report Number
    1821850-2024-00001
    Event Type
    Malfunction
    Date Received
    March 25, 2024
    Date of Event
    February 24, 2024
    Report Date
    March 21, 2024
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, CUSTOMER COMPLAINT OF DEVICE FUNCTIONING INITIALLY AND THEN STOPPING WAS CONFIRMED. THE DEVICE HAS BEEN IN SERVICE FOR 10 YEARS BUT HAS NOT BEEN BACK FOR FACTORY SERVICE. RECOMMENDED REPLACEMENT OF THE MEMBRANE SWITCH, TURBIN VALAVE ASSEMBLY AND THE TIMING REGULATOR, ALL OF WHICH WOULD HAVE BEEN ADDRESSED HAD FACTORY MAINTENANCE BEEN PERFORMED AT THE RECOMENDED 5 YEAR INTERVALS. CUSTOMER DECLINED THE REPAIRS AND INDICATED THEY WOULD TAKE IT OUT OF SERVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE RUNS FOR 10 MINUTES AND THEN THE COMPRESSIONS START TO STOP OR BIND UP. IT WAS REPORTED THAT THE PROBLEM OCCURRED WHEN IN USE ON A PATIENT, AND MANUAL COMPRESSIONS WERE RESUMED. PAITENT WAS NOT REVIVED. IT IS THE OPERATOR'S OPINION THAT THE PROBLEM WITH THE DEVICE DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525607 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male