BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOVERMATT LATERAL PATIENT TRANSFER DEVICE

    MDR report key: 1942917 · Received December 22, 2010

    Report

    Report Number
    2531468-2010-00002
    Event Type
    Other
    Date Received
    December 22, 2010
    Date of Event
    November 25, 2010
    Report Date
    December 13, 2010
    Manufacturer
    D.T. DAVIS ENTERPRISES LTD., HOVERTECH INTL
    Product Code
    FRZ
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LABEL ON THE HOVERMATT CLEARLY STATES: "DO NOT LEAVE PT UNATTENDED ON INFLATED HOVERMATT." THE INCIDENT WAS CAUSED BY STAFF ERROR, THE PT WAS LEFT UNATTENDED WHILE THE HOVERMATT WAS STILL INFLATED. ACCORDING TO THE HOSPITAL DESCRIPTION FORM THE STAFF HAS BEEN RETRAINED BY THE FACILITY KEY OPERATORS. THE INDIVIDUAL INTERVIEWED DID STATE THAT IT WAS A NURSING ERROR, LEAVING THE PUMP RUNNING, THE SIDE RAIL DOWN, AND LEAVING THE PT UNATTENDED.

    Description of Event or Problem · 1

    THE DIALYSIS UNIT WAS USING A HOVERMATT WITH THE (B)(4) PUMP ON AN IN-PATIENT WITH AN (B)(4). THE STAFF HAD THE MOTOR RUNNING AT LOW PRESSURE TO RELIEVE THE DISCOMFORT FOR THE PT. THE STAFF HAD LOWERED THE SIDE RAIL ON THE STRETCHER AND LEFT THE PT UNATTENDED. WHEN THE RESIDENT SHIFTED HIS WEIGHT WITH THE MOTOR RUNNING AT LOW PRESSURE THE HOVERMATT WAS INFLATED ENOUGH TO HAVE HIM SLIP OFF THE STRETCHER. NARRATIVE WAS TAKEN DIRECTLY FROM THE HOSPITAL DESCRIPTION FORM: (B)(4).

    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., HOVERTECH INTL HM34HS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization