BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOVERMATT LATERAL TRANSFER MATTRESS

    MDR report key: 5401221 · Received February 1, 2016

    Report

    Report Number
    5401221
    Event Type
    Malfunction
    Date Received
    February 1, 2016
    Date of Event
    January 7, 2016
    Report Date
    January 28, 2016
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD
    Product Code
    FRZ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN OPERATING ROOM FOR LAPAROSCOPIC APPENDECTOMY. THE PATIENT HAD BEEN PLACED ON HOVERMATT TRANSFER MATTRESS. THE OPERATING ROOM TABLE WAS TILTED HEAD DOWN AND TO THE LEFT AT THE REQUEST OF THE SURGEON. BECAUSE OF THE HOVERMATT, THE PATIENT'S BODY STARTED TO SLOWLY SLIDE OFF OF THE OPERATING ROOM TABLE. SURGEON AND ANESTHESIOLOGIST, WHO WAS AT THE HEAD OF THE TABLE) ATTEMPTED TO CATCH THE PATIENT BUT HE WAS UNABLE TO STOP PATIENT FROM SLIDING DOWN. SURGEON HAD TO GUIDE THE PATIENT TO THE FLOOR WITH HIMSELF UNDERNEATH THE PATIENT TO PROTECT THE PATIENT FROM INJURY. THE HOVERMATT WAS UNDER THE PATIENT, BUT ALL OF THE EDGES HAD BEEN TUCKED UNDERNEATH THE MATTRESS. THE OPERATING ROOM TABLE SAFETY STRAPS WERE ACROSS THE PATIENT'S THIGHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61144 HOVERMATT LATERAL TRANSFER MATTRESS DEVICE, PATIENT TRANSFER FRZ D.T. DAVIS ENTERPRISES LTD HM34SPU

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR