BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT

    MDR report key: 1913478 · Received November 24, 2010

    Report

    Report Number
    1313850-2010-00008
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    IKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SERVICE REPORT THAT THE XPRT MATTRESS PENDANT WAS DARK AND NOT FUNCTIONING. SERVICE INSPECTION OF THE FOOT BOX IDENTIFIED A PINCHED POWER IN THE BED FRAME. THE POWER CORD WAS FRAYED. NO PATIENT OR USER INVOLVEMENT. NO ADVERSE CONSEQUENCES HAVE BEEN REPORTED. EVENT DATE WAS APPROXIMATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XPRT POWERED FLOTATION THERAPY MATTRESS IKY GAYMAR INDUSTRIES, INC. 2950300000

    Patients

    Seq Age Sex Outcome Treatment
    1