BEUDAMED
    FDA Adverse Event Death Summary report: N

    VOYAGER DUO

    MDR report key: 4113797 · Received August 21, 2014

    Report

    Report Number
    9681684-2014-00053
    Event Type
    Death
    Date Received
    August 21, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    ARJOHUNTLEIGH HAS BEEN INFORMED BY THE LAWSUIT THAT: "MR. (B)(6) LIVED AT HOME WITH HIS WIFE WHO SUFFERED FROM FAIRLY ADVANCED ALZHEIMER. MR. (B)(6) USED THIS LIFT TO GET OUT OF BED AND TO TRANSPORT HIM TO HIS WHEELCHAIR WHICH HE THEN USED TO MOVE THROUGHOUT THE HOME. ON THIS DAY HE WAS IN THE LIFT AND WAS GOING TO HIS CHAIR WHEN THE LIFT STOPPED - HE COULD NOT GET BACK TO THE BED OR TO THE CHAIR. THERE IS A RED EMERGENCY CORD WHICH HE PULLED AND IT DID NOT WORK - HE SOMEHOW SLIPPED THROUGH THE HARNESS AND IT PINNED HIS ARMS ABOVE HIM HEAD. HE REMAINED IN THIS POSITION FOR SEVERAL HOURS UNTIL HIS WIFE'S AT HOME NURSE CAME AND FOUND HIM. 911 WAS CALLED BUT IT WAS TOO LATE- HE SUFFERED SEVERE INJURIES TO LEGS AND ARMS, SUBSEQUENTLY HE WENT INTO RENAL FAILURE AND PASSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506180 VOYAGER DUO FSA ARJOHUNTLEIGH MAGOG INC 9130009

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death