BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOVERMATT

    MDR report key: 4449582 · Received December 22, 2014

    Report

    Report Number
    2531468-2014-00001
    Event Type
    Death
    Date Received
    December 22, 2014
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD.
    Product Code
    FRZ
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014, HOVERTECH'S QUALITY MANAGER LEARNED OF THE INCIDENT OF THE PATIENT FALLING OUT OF BED WITH INJURY. AT THIS TIME WE BELIEVED THIS TO BE A 30 DAY REPORT. MANUFACTURER WAS INFORMED OF THE STATUS OF THE PATIENT AT A MUCH LATER DATE. THE REPORT FROM (B)(6) WAS NOT RECEIVED UNTIL (B)(6) 2014. NO CAUSE OF DEATH WAS RECORDED. THE MANUFACTURER'S REPORT HAS BEEN SENT TO THE FDA WITHIN 5 DAYS OF BEING NOTIFIED OF THE PATIENT'S PASSING. THERE IS NO INFORMATION IN THE FACILITY REPORT THAT INDICATES THE UNINFLATED HOVERMATT (LATERAL TRANSFER DEVICE) CONTRIBUTED TO THE PATIENT FALL AND SUBSEQUENT INJURIES: THE LATERAL TRANSFER DEVICE WAS NOT IN USE WHEN THE INCIDENT OCCURRED.; THE PATIENT HAD BEEN SLEEPING ON THE UNINFLATED LATERAL TRANSFER DEVICE.; ONLY 3 OF THE 4 BED RAILS WERE EMPLOYED WHEN THE INCIDENT OCCURRED.; HOVERTECH'S INSTRUCTIONS FOR USE PROVIDED ACCORDING TO REGULATION ON THE EQUIPMENT AND IN THE USER'S MANUAL CLEARLY STATE THAT THE BED RAILS SHOULD BE RAISED AFTER THE HOVERMATT IS DEFLATED. WE ARE COORDINATING RETRAINING WITH THE FACILITY.

    Description of Event or Problem · 1

    REFERENCE UF/IMPORTER # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843802 HOVERMATT DEVICE, PATIENT TRANSFER, POWERED. FRZ D.T. DAVIS ENTERPRISES LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1