BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAXIMOVE

    MDR report key: 2312361 · Received October 26, 2011

    Report

    Report Number
    9681684-2011-00077
    Event Type
    Death
    Date Received
    October 26, 2011
    Date of Event
    September 28, 2011
    Report Date
    September 29, 2011
    Manufacturer
    BHM MEDICAL, INC.
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY (B)(4) ON BEHALF OF THE MANUFACTURER BHM MEDICAL, INC. (REGISTRATION #(B)(4)). AFTER THE INCIDENT, THE SLING HAS BEEN TAKEN OUT BY (B)(6). THE MFR'S SERVICE SALES UNIT IS IN CONSULTATION WITH THEM TO HAVE THE SLING BACK FOR THOROUGH INVESTIGATION. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    PT WAS BEING PREPARED FOR A TRANSFER FROM BED WITH A SLING AND A MAXIMOVE FLOOR LIFT. SLING WAS PLACED UNDERNEATH HER AND THE DEVICE WAS BEING DRIVEN UNDER THE BED. CLIPS OF THE SLING WERE FIXED TO THE SPREADER BAR AND PT WAS GIVEN THE HANDSET. SHE THEN PUSHED ON THE HANDSET HERSELF SO THE DEVICE WENT UP. THE DEVICE WAS DRIVEN FROM ABOVE THE BED TO GO IN THE DIRECTION OF THE SHOWER. AT THIS MOMENT, THE RIGHT LEG CLIP SHUT LOOSE, WHICH MADE THE CLIENT FALL ONTO THE FLOOR. IT HAS BEEN REPORTED THAT THE PT EXPIRED AS A CONSEQUENCE OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMOVE MANUFACTURED FLOOR PASSIVE LIFT FSA BHM MEDICAL, INC. KMCSXE-D

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death