BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUADIS 56

    MDR report key: 24764089 · Received April 2, 2026

    Report

    Report Number
    9616031-2026-0000003
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 2, 2026
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153710351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    GETINGE DISINFECTION AB (GETINGE) RECEIVED INFORMATION OF SMOKE COMING FROM BOTTOM OF THE WASHER UNIT AQUADIS 56M. DURING TROUBLESHOOTING, IT WAS IDENTIFIED THAT THE CAPACITOR FOR THE DRAIN MOTOR HAD SHORTED AT THE TERMINAL. A REPLACEMENT PART WAS REQUIRED AND ORDERED, RESULTING IN A RETURN VISIT TO INSTALL A NEW CAPACITOR. SUBSEQUENTLY, THE DRAIN PUMP WAS REPLACED, AND THE UNIT IS NOW OPERATING AS DESIGNED AND HAS SUCCESSFULLY PASSED ALL FUNCTIONAL TESTING. MANUFACTURER HAS REQUESTED THE RETURN OF THE PART FOR FURTHER ANALYSIS. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824893 AQUADIS 56 DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 56M 07340153710351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown