BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AQUADIS 56

    MDR report key: 22677260 · Received July 31, 2025

    Report

    Report Number
    3013876692-2025-00064
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 16, 2025
    Report Date
    April 8, 2026
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    07340153710351
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    GETINGE DISINFECTION AB (GETINGE) RECEIVED INFORMATION THAT THE WASHER DOOR LOCKING BODY ON THE AQUADIS 56M CRACKED. ACCORDING TO THE GETINGE TECHNICIAN, DUE TO THE CRACK IN THE PLASTIC COMBINED WITH HEAT FROM THE CYCLE TEMPERATURE ACTIVATED A REACTION RESULTING IN A RELEASE OF STRONG CHEMICAL ODOUR. FOLLOWING EXPOSURE TO THE ODOUR DURING A WASH CYCLE, STAFF MEMBERS REPORTED HEALTH SYMPTOMS INCLUDING COUGHING, SORE THROAT, BREATHING AND SWALLOWING DIFFICULTIES AND BURNING EYES. SOME INDIVIDUALS UNDERWENT MEDICAL EVALUATION AND TREATMENT, INCLUDING X-RAY EXAMINATION, BLOOD TESTS, AND PRESCRIPTION OF INHALERS ("PUFFERS"). HOWEVER, THE FULL EXTENT OF EXPOSURE AND POSSIBLE HEALTH EFFECTS FOR ALL INDIVIDUALS REMAINS UNKNOWN. THE INVESTIGATION DETERMINED THAT DEGRADATION OF THE POLYOXYMETHYLENE (POM) DOOR LOCK COMPONENT WAS MOST LIKELY CAUSED BY EXPOSURE TO AN EXTERNAL ACIDIC AND/OR CHLORINATED CHEMICAL, WHICH IS INCONSISTENT WITH APPROVED PROCESS CHEMISTRY. UNDER SUCH CONDITIONS (ACIDIC ENVIRONMENT AND ELEVATED TEMPERATURE), POM MAY DEGRADE AND RELEASE FORMALDEHYDE, A KNOWN RESPIRATORY IRRITANT. BASED ON THE EXTERNAL LABORATORY ANALYSIS, IT IS CONCLUDED THAT A CLEANING AGENT REACTING WITH POM MOST LIKELY HAVE BEEN APPLIED TO THE DOOR LOCK BODY LOCATED ON THE SOIL SIDE OF THE AFFECTED UNIT. THEREFORE, THE EVENT IS CONSIDERED TO BE THE RESULT OF USER ERROR. PARTS HAVE BEEN REPLACED, DEVICE WAS REPAIRED AND PUT BACK IN USE, THE ODOUR WAS NOT PRESENT AFTER THE REPAIR. THE USER HAS BEEN INFORMED REGARDING PROPER MAINTENANCE PROCEDURES FOR THE DEVICE. IT HAS BEEN ADDITIONALLY REPORTED ON MARCH 20TH 2026 THAT AT THE TIME OF THE INCIDENT, FIVE PERSONS WERE PRESENT IN THE ROOM. AS THE FULL MEDICAL STATUS OF ALL INDIVIDUALS IS NOT CONFIRMED, AND OUT OF AN ABUNDANCE OF CAUTION, FOUR ADDITIONAL REPORTS ARE BEING SUBMITTED TO COMPLY WITH THE REQUIREMENT OF ONE REPORT PER POTENTIALLY EXPOSED INDIVIDUAL. THE REMAINING FOUR REPORTS NUMBERS RELATED TO THIS INCIDENT ARE: 9616031-2026-0000005; 9616031-2026-0000004; 9616031-2026-0000006; 9616031-2026-0000007.

    Description of Event or Problem · 0

    GETINGE HAS BEEN AWARE ABOUT A CHEMICAL ODOR FROM WASHER DISINFECTOR AQUADIS 56-SERIES, MODEL NAME 56M. THE ODOR LED TO HEALTH SYMPTOMS REPORTED BY STAFF INCLUDING COUGHING, SORE THROAT, AND BREATHING ISSUES. SEVERAL INDIVIDUALS REQUIRED MEDICAL TESTING AND TREATMENT. IN RESPONSE, THE UNIT WAS TAKEN OUT OF SERVICE. REF # (B)(4).

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110268 AQUADIS 56 DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 56M 07340153710351

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other