BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 3198486 · Received June 24, 2013

    Report

    Report Number
    2531468-2013-00001
    Event Type
    Other
    Date Received
    June 24, 2013
    Date of Event
    April 26, 2013
    Report Date
    June 21, 2013
    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

    THE FDA REPORT WAS RECEIVED BY HOVERTECH ON (B)(4) 2013. THE FACILITY NEVER REPORTED THE INCIDENT TO D.T. DAVIS ENTERPRISES. (B)(6) WAS CONTACTED ON (B)(4) 2013 AND A MESSAGE WAS LEFT; A FOLLOW-UP E-MAIL WAS SENT. (B)(6) RETURNED THE CALL ON (B)(6) 2013. (B)(6) STATED THAT DESPITE THE FACT, THE REPORT STATED THE PT FELL, THIS WAS NOT THE CASE. THE PT DID NOT FALL AND THERE WERE NO INJURIES DUE TO THE INCIDENT WITH THE HOVERMATT. A STRAP TORE AWAY FROM THE TOP OF THE HOVERMATT BUT REMAINED INTACT. THE EMPLOYEE PULLED THE PT SAFETY STRAP TO PREVENT THE PT FROM FALLING. SINCE THE STITCHING TORE, THE HOVERMATT WAS REMOVED FROM SERVICE AND PLACED IN (B)(6)'S OFFICE. HE SAID THE MATT WOULD BE RETURNED TO HOVERTECH FOR REVIEW AND HE WOULD HELP FILL IN THE MISSING INFORMATION. NO REPLY WAS RECEIVED AND THE DEVICE WAS NOT RETURNED AT THIS TIME. THE MANUEL STATES, "PT SAFETY STRAPS (2) DO NOT USE TO TRANSFER." THE PT SAFETY STRAPS ARE TO SECURE THE PT ON THE HOVERMATT, THEY ARE NOT MEANT FOR TRANSFERRING/PULLING. SINCE THE HOVERMATT WAS NOT RETURNED, A FULL EVAL COULD NOT BE COMPLETED.

    Description of Event or Problem · 1

    PT FELL WHILE BEING TRANSFERRED FROM A HOSPITAL BED TO A TRANSPORT STRETCHER USING A HOVERMATT MATTRESS. DURING THE TRANSFER, THE PT RESTRAINING STRAPS TORE AWAY FROM THE MATTRESS. THE EMPLOYEES INFLATED THE HOVERMATT AND LATERALLY TRANSFERRED THE PT FROM THE BED TO THE STRETCHER. THE HOVERMATT STRAPS WERE INTACT AND SECURED DURING THE TRANSFER. ONCE THE PT WAS ON THE STRETCHER, ONE OF THE EMPLOYEES ATTEMPTED TO RAISE THE OUTSIDE SIDE RAIL WHILE THE HOVERMATT WAS STILL INFLATED. THE STRETCHER MOVED SLIGHTLY AND THE HOVERMATT SLID OFF THE STRETCHER. ONE OF THE EMPLOYEES GRABBED THE UPPER STRAP TO PREVENT THE HOVERMATT AND PT FROM FALLING. THE RIGHT UPPER STRAP WAS PULLED OFF WHEN THE EMPLOYEE GRABBED IT. THE STRAP DID NOT RIP APART FROM THE MATTRESS, THE THREADS WERE TORN. MATTRESS SERIAL NUMBER MODEL NUMBER HM34HS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284889 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