BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXISKY 600

    MDR report key: 2223537 · Received July 22, 2011

    Report

    Report Number
    9681684-2011-00054
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    April 30, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BHM MEDICAL INC.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 BHM MEDICAL, INC (B)(4). ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    THE (B)(6) REPORTED THAT WHILE THE PT WAS BEING TRANSFERRED TO THE BED WITH A MAXISKY 600, HER BOTTOM SKIMMED THE EDGE OF THE BED AND ONE OF THE CLIPS ON THE LEG SECTION DISCONNECTED FROM THE SPREADER BAR. THE PT FELL OUT OF THE SLING AND THE CARERS WERE ABLE TO BLOCK THE FALL AND PUSHED THE PT FULLY ONTO THE BED. NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXISKY 600 MANUFACTURED CELING FIXED CASSETTES FNG BHM MEDICAL INC. LD10200

    Patients

    Seq Age Sex Outcome Treatment
    1 Other