BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    V3

    MDR report key: 2910222 · Received November 23, 2012

    Report

    Report Number
    9681684-2012-00089
    Event Type
    Malfunction
    Date Received
    November 23, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ARJOHUNTLEIGH MAGOG INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MANUFACTURER ARJOHUNTLEIGH (B)(4). THE DEVICE WAS INSPECTED ON-SITE BY A REPRESENTATIVE OF THE MANUFACTURER¿S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MANUFACTURER. THE DEVICE WAS FOUND IN GOOD CONDITION. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER¿S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS BEING TRANSFERRED TO THE BED FROM A COMMODE WITH A PORTABLE CEILING LIFT FIXED TO THE TROLLEY ON TRACK BY A CARABINER. THE STAFF REPORTED HEARING A CRACK OR SNAP, THEN THE RESIDENT AND DEVICE DROPPED ON THE BED. THE REACHER STAYED ATTACHED TO THE TROLLEY ON THE TRACK, THE RESIDENT SUSTAINED A BUMP ON HIS HEAD WHICH DID NOT REQUIRE ANY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 V3 MANUFACTURED PORTABLE CASSETTES FNG ARJOHUNTLEIGH MAGOG INC. 9810001

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR