BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

    MDR report key: 6846806 · Received September 6, 2017

    Report

    Report Number
    3005619970-2017-00024
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Date of Event
    August 15, 2017
    Report Date
    September 6, 2017
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012066 BY GETINGE (SUZHOU) CO., LTD. (REGISTRATION #(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. AHUS (REGISTRATION #(B)(4). ARJOHUNTLEIGH WAS MADE AWARE AN THE INCIDENT WHICH OCCURRED WITH THE INVOLVEMENT OF A NON-ARJOHUNTLEIGH PRODUCT.

    Description of Event or Problem · 0

    ARJOHUNTLEIGH WAS MADE AWARE OF AN INCIDENT WHICH OCCURRED WITH THE INVOLVEMENT OF A NON-ARJOHUNTLEIGH PRODUCT. IT WAS INDICATED THAT THE CAREGIVER ATTEMPTED TO MOVE THE BED WHICH LED TO THE ENTRAPMENT OF PUMP POWER CABLE WITHIN THE BED MECHANISM. CONSEQUENTLY, LIVE AND NEUTRAL WIRES OF THE PUMP WERE EXPOSED. THE CAREGIVER PICKED UP THE CABLE WITH HIS BARE HAND, WHEN THE PUMP WAS STILL PLUGGED TO MAINS SUPPLY WHICH RESULTED IN ELECTRICAL SHOCK. IT WAS INDICATED THAT THE CAREGIVER VISITED EMERGENCY DEPARTMENT, HOWEVER, DID NOT SUSTAIN ANY FURTHER OUTCOMES. ARJOHUNTLEIGH HAVE MANAGED TO IDENTIFY THE ORIGINAL MANUFACTURER OF INVOLVED DEVICE - THE COMPANY'S NAME IS BELIEVED TO BE ULTIMATE HEALTHCARE, DEVICE SERIAL NUMBER: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624449 MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE FNM

    Patients

    Seq Age Sex Outcome Treatment
    1