BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOYAGER

    MDR report key: 2475549 · Received February 24, 2012

    Report

    Report Number
    9681684-2012-00023
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG
    Product Code
    FNG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (B)(4) ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE EVAL OF THE DEVICE OF DATE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MFR BY THE IMPORTER OF THE DEVICE THAT AN INCIDENT OCCURRED INVOLVING A VOYAGER PORTABLE CASSETTE. RESIDENT WAS BEING TRANSFERRED FROM HER BED TO HER WHEELCHAIR. TWO AIDES FRONT AND IN BACK OF HER RAISED HER OFF OF THE BED ABOUT 3 FEET OFF OF THE FLOOR, WHEN THEY CLEARED THE BED IN BETWEEN THE BED AND THE WHEELCHAIR THE CARABINEER HOOK DISCONNECTED FROM THE REACHER BAR. RESULTING IN THE LIFT/PT FALLING TO THE FLOOR. THE AIDE WAS ABLE TO DEFLECT THE LIFT TO LAND ON THE BED. THE RESIDENT HIT THE FLOOR FRACTURING HER RIGHT HEEL AND HER HEAD LANDED ON THE AIDES FOOT. AFTERWARD STAFF CALLED THE AMBULANCE AND RUSHED HER TO (B)(6) HOSPITAL. LIFT WAS REMOVED FROM SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER MANUFACTURED PORTABLE CASSETTES FNG ARJOHUNTLEIGH MAGOG VOYAGER

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| O| R