BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPRT

    MDR report key: 1913477 · Received November 24, 2010

    Report

    Report Number
    1313850-2010-00009
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 23, 2010
    Manufacturer
    GAYMAR INDUSTRIES, INC.
    Product Code
    FNM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A SERVICE REPORT THAT THE MATTRESS INDICATES A NEED FOR 'SERVICE'. SERVICE INSPECTION OF THE FOOT BOX IDENTIFIED THE BLACK POWER CABLE EXITING FROM THE MOTOR WAS SEVERED. 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 FNM GAYMAR INDUSTRIES, INC. 2950200000

    Patients

    Seq Age Sex Outcome Treatment
    1