BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 19874288 · Received July 31, 2024

    Report

    Report Number
    1821850-2024-00002
    Event Type
    Malfunction
    Date Received
    July 31, 2024
    Report Date
    July 31, 2024
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE USER FACILITY BIOMED DEPARTMENT EVALUATED THE DEVICE FIRST AND FOUND NO PROBLEM. THEY THEN RETURNED THE DEVICE TO THE MANUFACTURER AS PER THEIR PROCEDURE. THE DEVICE WAS THOROUGHLY EVALUATED AND NO PROBLEMS WERE FOUND. IT WAS ACCEPTED AND TESTED TO FACTORY SPECIFICATIONS AND RETURNED TO THE USER. IT WAS COMMUNICATED BY THE USER FACILITY BIOMED DEPARTMENT THAT THE MOST LIKELY CAUSE IS THE USER DID NOT PROPERLY ATTACH THE O2 INPUT HOSE THE WALL SOURCE, AND THE DEVICE RAN OUT OF OXYGEN. FURTHER INFORMATION COULD NOT BE OBTAINED FROM THE USER FACILITY.

    Description of Event or Problem · 0

    DEVICE WAS REPORTED TO HAVE STOPPED OPERATING DURING A CODE. THE BIOMED DEPARTMENT OF THE USER FACILITY TOOK POSSESSION OF THE DEVICE AND COULD NOT FIND A PROBLEM. IT WAS SUGGESTED BY THE BIOMED DEPARTMENT THAT THE MOST LIKELY CAUSE IS THE USER DID NOT PROPERLY ATTACH THE O2 INPUT HOSE (POWER SOURCE) TO THE WALL SOURCE AND THE DEVICE RAN OUT OF OXYGEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216858 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Unknown