BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER

    MDR report key: 2475601 · Received February 27, 2012

    Report

    Report Number
    9681684-2012-00018
    Event Type
    Malfunction
    Date Received
    February 27, 2012
    Date of Event
    January 31, 2012
    Report Date
    February 3, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG, INC
    Product Code
    FNG
    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 ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE EVAL OF THE DEVICE TO 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

    AS REPORTED BY STAFF ON (B)(6) 2012: "THE CAREGIVER WAS GOING TO LIFT THE RESIDENT FROM A SHOWER CHAIR TO THE BED USING A PORTABLE CEILING LIFT SECURED TO THE TRACK SYSTEM WITH A CARABINEER CLIP. WHILE RAISING THE RESIDENT, AT ABOUT 2 OR 3 INCHES OFF OF THE CHAIR, THE CAREGIVER HEARD A POP NOISE, LOOKED UP, AND NOTICED THAT THE CARABINEER HOOK SPRING SHAFT HAD SPRUNG OPEN OUT OF THE HOOK. THE CAREGIVER LOWERED THE RESIDENT BACK DOWN IN THE SHOWER CHAIR. NO INJURIES WERE SUSTAINED BY THE RESIDENT OR THE CAREGIVER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other