BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PT TRANSFER DEVICE

    MDR report key: 2181520 · Received July 14, 2011

    Report

    Report Number
    2531468-2011-00002
    Event Type
    Other
    Date Received
    July 14, 2011
    Date of Event
    June 10, 2011
    Report Date
    July 12, 2011
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD., T/A HOVERTECH INTL
    Product Code
    IKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE INCIDENT WAS NOT REMOVED FROM SERVICE AND IS STILL IN USE AT THE FACILITY. SINCE THE DEVICE INVOLVED IN THE INCIDENT WAS NOT RETURNED AN (B)(4) FROM DEMO STOCK WAS EVALUATED. USING A (B)(6) WEIGHT TO RECREATE THE SITUATION THE ALLEGED FAILURE COULD NOT BE DUPLICATED. THE HOSP STAFF INVOLVED IN THE INCIDENT HAS BEEN RETRAINED IN THE USE OF THE HOVERMATT PT TRANSFER DEVICE.

    Description of Event or Problem · 1

    TWO HOSP STAFF HAD COMPLETED A PROCEDURE AT THE X-RAY TABLE AND HAD TRANSFERRED THE PT TO THE STRETCHER. THE STAFF HAD LIFTED THE SIDES OF THE STRETCHER AND LOCKED THEM IN PLACE. THEY THEN TURNED OFF THE HOVERMATT PUMP. AS THE MATT WAS DEFLATING THE RESIDENT MOVED TO ONE SIDE. STAFF STATED THAT WHEN THIS OCCURRED THE AIR IN THE HOVERMATT RUSHED TO ONE SIDE, LIFTED THE RESIDENT UP IN THE AIR AND OVER THE EDGE OF THE STRETCHER SIDE RAIL AND THE PT FELL TO THE FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVERMATT LATERAL PT TRANSFER DEVICE DEVICE, PT TRANSFER, POWERED IKX D.T. DAVIS ENTERPRISES LTD., T/A HOVERTECH INTL HM34HS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization