BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GETINGE 46-SERIES

    MDR report key: 3368406 · Received September 13, 2013

    Report

    Report Number
    9616031-2013-00004
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    August 13, 2013
    Report Date
    August 14, 2013
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MDZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED REMOTELY (NOT RETURNED TO MANUFACTURER) VIA INVESTIGATION REPORTS AND PHOTOGRAPHS FROM GETINGE (B)(4)., A SERVICE UNIT LOCATED IN (B)(4). IT WAS CONCLUDED THAT THE OVERHEAT PROTECTION SYSTEM FAILED/DELAYED RESPONSE TO AN OVERHEAT CONDITION. A VOLUNTARY DEVICE CORRECTION OF GETINGE MODEL 46-4 WASHER DISINFECTORS WAS REPORTED TO U.S. FDA ON (B)(4) 2013 (RECALL NUMBER NOT YET ASSIGNED). THIS CORRECTION WAS INITIATED TO ADDRESS TWO CONDITIONS. A POTENTIAL TRIGGER FOR OVERHEATING; (ROOT CAUSE) - INADEQUATE OVERHEAT PROTECTION SYSTEM COMPONENT. A COMPONENT (SHUNT TRIP) SELECTED FOR THE OVERHEAT PROTECTION SYSTEM DOES NOT MEET THE REQUIRED PARAMETERS (CONTROL VOLTAGE) WHERE/WHEN OVERHEATING OCCURS. THE CORRECTION ENTAILS - INSPECTING THE SETTING OF A SOFTWARE FUNCTION THAT CAN BE UTILIZED DURING SERVICING OF A UNIT TO SKIP WASH PHASES. THIS IS A PASSWORD PROTECTED FUNCTION BUT IF LEFT IN THE ENABLED STATE, A USER CAN INADVERTENTLY ACTIVATE THE HEATING ELEMENT WITH NO WATER IN THE CHAMBER. THE DEVICE CORRECTION ACTION INCLUDES INSPECTING THAT THIS FUNCTION IS NOT ENABLED. THE INSTALLATION OF A NEWER DESIGN OF OVERHEAT PROTECTION SYSTEM THAT UTILIZES A HEATING ELEMENT WITH INTEGRAL THERMAL FUSES THAT MEET THE REQUIRED OVERHEAT PARAMETERS. RECALL NUMBER NOT YET ASSIGNED.

    Description of Event or Problem · 1

    SMOKE/FIRE WAS OBSERVED COMING FROM A GETINGE MODEL 46-4 WASHER DISINFECTOR DURING USE. THE WASHER WAS APPROX 35-40 MINUTES INTO A 70 MINUTE CYCLE WHEN STAFF OBSERVED SMOKE/FIRE. THE USER'S TURNED OFF THE POWER TO THE UNIT AND SPRAYED WITH A DRY POWDER EXTINGUISHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462053 GETINGE 46-SERIES WASHER DISINFECTOR MDZ GETINGE DISINFECTION AB 46-4

    Patients

    Seq Age Sex Outcome Treatment
    1