BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE 46-SERIES

    MDR report key: 3370958 · Received August 22, 2013

    Report

    Report Number
    9616031-2013-00003
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 22, 2013
    Report Date
    July 23, 2013
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE EVAL IS CURRENTLY IN-PROGRESS. A VOLUNTARY DEVICE CORRECTION OF GETINGE MODEL46-4 WATER DISINFECTORS WAS REPORTED TO US FDA ON 07/26/2013. THIS CORRECTION WAS INITIATED TO ADDRESS A SOFTWARE FUNCTION THAT CAN BE UTILIZED DURING SERVICING OF THE UNIT. THIS IS A PASSWORD PROTECTED FUNCTION BUT IF LEFT IN THE ENABLED STATE, A USER COULD INADVERTENTLY ACTIVATE THE HEATING ELEMENT WITHOUT WATER IN THE CHAMBER WHICH COULD LEAD TO AN OVERHEAT CONDITION. THE DEVICE CORRECTION ACTIONS INCLUDE INSPECTING THAT THIS FUNCTION IS NOT ENABLED AND TO INSTALLED A HEATING ELEMENT WITH INTEGRAL THERMOSTAT TO ADDRESS THE DELAYED OVERHEAT PROTECTION. THE INCIDENT SUBJECT OF THIS MDR IS STILL BEING INVESTIGATED TO DETERMINE ITS CAUSE AND TO EVALUATE IF ANY ADDITIONAL CORRECTIVE ACTIONS ARE REQUIRED AS A RESULT OF THIS INCIDENT. NO FLAME WAS REPORTED IN THIS INSTANCE THOUGH ELECTRICAL WIRING AND COMPONENTS WERE DAMAGED IN THE WASHER DISINFECTOR. NO DAMAGE TO THE FACILITY OR INJURY TO INDIVIDUALS WERE REPORTED. A F/U MDR WILL BE SUBMITTED AT THE CONCLUSION OF THIS INCIDENT INVESTIGATION.

    Description of Event or Problem · 1

    SMOKE WAS OBSERVED COMING FROM A GETINGE MODEL 46-4 WASHER DISINFECTOR DURING USE. THE CUSTOMER SHUT OFF THE UNIT. NO INJURIES OR DAMAGE TO THE FACILITY HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408440 GETINGE 46-SERIES WASHER DISINFECTOR MDZ GETINGE DISINFECTION AB 46-4

    Patients

    Seq Age Sex Outcome Treatment
    1