BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CM320-SERIES

    MDR report key: 24751863 · Received April 1, 2026

    Report

    Report Number
    9616031-2026-0000002
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 1, 2026
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE DISINFECTION AB RECEIVED A REPORT OF AN ELECTRICAL FIRE IN A WASHER DISINFECTOR. NO INJURIES OCCURRED, AND FLAMES BECAME VISIBLE ONLY AFTER REMOVAL OF THE SERVICE PANEL. DURING THE INITIAL SERVICE ACTIVITIES ALL RELEVANT COMPONENTS WERE REPLACED, INCLUDING BOTH ELEMENT CABLES, AND THE HEATING ELEMENTS WERE INSTALLED. FOLLOWING THESE ACTIONS, THE UNIT DID NOT RESET UPON APPLICATION OF POWER. THE NEWLY INSTALLED THERMOSTAT WAS RESET, AND THE CHAMBER RAIL WAS REINSTALLED. SUBSEQUENT FUNCTIONAL TESTING, INCLUDING MULTIPLE TEST CYCLES, DEMONSTRATED NORMAL SYSTEM OPERATION. ALL TESTS PASSED AND NO LEAKS WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION FROM THE COMPLAINT AND THE ASSESSMENT CONDUCTED BY SSU TECHNICIANS, INCREASED CONTACT RESISTANCE AT SCREW CONNECTIONS HAS BEEN IDENTIFIED AS THE MOST PROBABLE CAUSE OF THE OVERHEATING CONDITION. THIS CONDITION MAY BE ASSOCIATED WITH GRADUAL LOOSENING OF SCREW CONNECTIONS OVER TIME DUE TO THERMAL CYCLING AND VIBRATION GENERATED DURING OPERATION OF THE ULTRASONIC UNIT. HOWEVER, IT IS IMPORTANT TO NOTE THAT THE ROOT CAUSE HAS NOT BEEN CONCLUSIVELY DETERMINED AT THIS STAGE. THE IDENTIFIED MECHANISM REPRESENTS A WORKING HYPOTHESIS SUPPORTED BY CURRENT OBSERVATIONS BUT HAS NOT BEEN DEFINITIVELY VERIFIED. IN ORDER TO ESTABLISH THE DEFINITIVE ROOT CAUSE, A CORRECTIVE AND PREVENTIVE ACTION (CAPA 1531116) HAS BEEN INITIATED FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. NO UDI IS AVAILABLE FOR THE AFFECTED DEVICE WITH CATALOG NUMBER CM320WD-CTOM, SINCE UDI WAS NOT REQUIRED WHEN THE DEVICE WAS MANUFACTURED IN 2013.

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    GETINGE DISINFECTION AB (GETINGE) RECEIVED INFORMATION THAT "ELECTRICAL FIRE" OCCURRED ON WASHER DISINFECTOR CM320-2 . IT WAS REPORTED THAT NO ONE WAS HARMED. FLAMES WERE VISIBLE ONLY AFTER REMOVING SERVICE PANEL. THE SERVICE TECHNICIAN CONFIRMED THAT THE AREA HAD BEEN SECURED. ROOM WAS BRIEFLY EVACUATED FOR AROUND 5 MINUTES. FIRE ALARM DID NOT SET OFF. AT THIS TIME, THE DEVICE IS NON-OPERATIONAL PENDING REPLACEMENT OF THE PART. A RETURN SERVICE VISIT WILL OCCUR TO REPLACE FAULTY PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816414 CM320-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB CM320-2

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown