BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 2418301 · Received January 10, 2012

    Report

    Report Number
    2531468-2011-00004
    Event Type
    Other
    Date Received
    January 10, 2012
    Report Date
    January 10, 2012
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD: T/A HOVERTECH INTERNATIONAL
    Product Code
    FRZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    D.T. DAVIS ENTERPRISES/HOVERTECH WAS INITIALLY CONTACTED BY A BIOMED TECHNICIAN FOR (B)(4) HOSPITAL ON 12/12/2011. HE NEEDED A COPY OF AN AIR SUPPLY MANUAL TO EVALUATE A HOVERMATT AND AIR SUPPLY THAT WAS INVOLVED IN AN INCIDENT. HE STATED THAT THE PATIENT WAS DROPPED WHILE LEFT UNATTENDED ON AN INFLATED HOVERMATT. THE LABEL ON THE HOVERMATT CLEARLY STATES "NEVER LEAVE PATIENT UNATTENDED ON AN INFLATED HOVERMATT AIR TRANSFER SYSTEM." THE BIOMED DEPARTMENT WAS TESTING THE DEVICES TO ENSURE THAT THEY WORKED PROPERLY. I EMAILED HIM A COPY OF OUR MANUAL AND ASKED WHO I SHOULD CONTACT TO GET MORE INFORMATION ABOUT THE INCIDENT AND PATIENT CONDITION. I CONTACTED THE (B)(6). (B)(6) RETURNED MY CALL ON 12/15/2011 AND SAID SHE WOULD CHECK INTO THE MATTER. SHE CALLED ME BACK TO LET ME KNOW THAT THEIR TESTING VERIFIED THAT THE HOVERMATT AND AIR SUPPLY WERE FUNCTIONING PROPERLY AND WERE NOT THE CAUSE OF THE INCIDENT. THE PATIENT HAD SUSTAINED AN ORBITAL FRACTURE BUT WAS DOING WELL. SHE DID NOT HAVE A SERIAL NUMBER FOR EITHER DEVICE. I E-MAILED HER A COPY OF THE REPORTING FORM TO GET ADDITIONAL INFORMATION. THE FORM WAS NEVER RETURNED. ON 12/19/2011 (B)(6), DEVICE REPORTING ANALYST, LEFT A MESSAGE. SHE STATED THAT BASED ON THE INFORMATION THAT THE FACILITY HAD THEY WOULD NOT MAKE A REPORT TO D.T. DAVIS ENTERPRISES/HOVERTECH, NOR TO THE FDA. THEIR TESTING SHOWED THAT THE HOVERMATT WAS NOT THE ISSUE AND THEY WERE WORKING ON OTHER AVENUES. I CALLED (B)(6) BACK TO DISCUSS THIS REPORT AND LET HER KNOW THAT WE COULD SEND A HOVERTECH REPRESENTATIVE TO RETRAIN THE STAFF ON USING THE HOVERMATT. I HAVE NOT RECEIVED A RETURN PHONE CALL. ALL TESTING WAS PERFORMED BY THE FACILITY. THE DEVICE WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS CONFIRMED THAT PATIENT SUSTAINED AN ORBITAL FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOVERMATT LATERAL PATIENT TRANSFER DEVICE DEVICE, PATIENT TRANSFER, POWERED FRZ D.T. DAVIS ENTERPRISES LTD: T/A HOVERTECH INTERNATIONAL HM34HS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other