BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE 46-SERIES

    MDR report key: 3134147 · Received May 15, 2013

    Report

    Report Number
    9616031-2013-00001
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 16, 2013
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AN OVERHEATING WAS REPORTED IN A 46-4 WASHER DISINFECTOR IN THE LOWER SIDE OF THE CHAMBER DURING THE DRYING PHASES. AFTER SOME TIME IT ESCALATED INTO FIRE. THE MACHINES OUTER PANEL PLATES CONTAINED THE FIRE AND PROTECTED THE SURROUNDING MATERIALS. THE OPERATOR TURNED OFF THE MAIN SWITCH AND USED AN EXTINGUISHER TO PUT OUT THE FIRE. SMOKE SPREAD TO NEARBY ROOMS. ONE PERSON REPORTED THROAT PAIN FROM THE SMOKE AND THE EXTINGUISHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216059 GETINGE 46-SERIES WASHER DISINFECTOR MDZ GETINGE DISINFECTION AB 46-4

    Patients

    Seq Age Sex Outcome Treatment
    1