BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXI SKY 600

    MDR report key: 1934701 · Received November 24, 2010

    Report

    Report Number
    9681684-2010-00050
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 24, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS IN BED WITH SLING AROUND HER, READY FOR THE TRANSFER. WHILE THE RESIDENT WAS BEING RAISED OFF BED, THE LEFT LEG STRAP DETACHED AND THE RESIDENT FELL 0.5 OR 1 INCH ONTO THE MATTRESS. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI SKY 600 LIFT, PATIENT, NON-AC POWERED FSA BHM MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other