BEUDAMED
    FDA Adverse Event Injury Summary report: N

    46-SERIES

    MDR report key: 16202876 · Received January 19, 2023

    Report

    Report Number
    9616031-2023-00002
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    January 9, 2023
    Report Date
    January 19, 2023
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    UDI-DI
    0734015370031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ON JANUARY 4TH, 2023, GETINGE BECAME AWARE OF AN ISSUE WITH THE 46-SERIES WASHER DISINFECTOR. AS IT WAS STATED THE MACHINE WAS LEAKING WATER. GETINGE SERVICE TECHNICIAN WAS CALLED TO REPAIR THE DEVICE AND DURING CLEANING THE INNER SIDE OF THE DOOR SURFACE WITH AN ALCOHOL THE TECHNICIAN CUT HIS FINGER ON A SHARP EDGE OF THE DOOR METAL PART. THE EDGE WAS KNIFE SHARP AND CUT THE BODY THROUGH THE TOWEL USED FOR CLEANING. THE TECHNICIAN NEEDED MEDICAL TREATMENT OF THE DEEP CUT WOUND IN INDEX FINGER - THE WOUND WAS GLUED. THE INJURY HAS BEEN CLASSIFIED AS SERIOUS AS MEDICAL INTERVENTION WAS NEEDED TO PRECLUDE LONG TERM CONSEQUENCES. AFTER INVESTIGATION BY A GETINGE SERVICE TECHNICIAN AND A MANUFACTURING SITE EXPERT, REGARDING THE ISSUE WITH THE CUT ON THE FINGER, ACCORDING TO THE HISTORICAL REVIEW THERE´S ONLY BEEN A SINGLE EVENT IN THIS REGARD. THE DRAWING STATES THAT THERE SHOULD BE NO SHARP EDGES ON THESE PLATES. WHEN THE INCIDENT OCCURRED, THE PRODUCT WAS DIRECTLY INVOLVED AND WAS NOT UP TO THE MANUFACTURER SPECIFICATION. THE DEVICE WAS NOT BEING USED FOR TREATMENT OR DIAGNOSIS OF THE PATIENT. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICE MANUFACTURING OR DEVICES ON THE MARKET, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION.

    Description of Event or Problem · 0

    ON JANUARY 4TH, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH THE 46-SERIES WASHER DISINFECTOR. AS IT WAS STATED THE MACHINE WAS LEAKING WATER FROM THE LOWER RIGHT HAND CORNER OF THE DOOR. THE GETINGE SERVICE TECHNICIAN VISITED CUSTOMER SITE ON (B)(6) 2023 AND INSPECTED THE DEVICE. NO LEAKAGE WAS FOUND, HOWEVER THE DOOR SWITCH ISSUE WAS NOTICED. MOREOVER, THE TEMPERATURE DURING WASH PHASE WAS NOT INCREASING PROPERLY. THE SOLENOID SWITCH WAS REPLACED AND THE DOOR SWITCH WAS ADJUSTED. THE DEVICE WAS TESTED AND RETURNED FOR USE IN OPERATIONAL STATE. ADDITIONALLY, DURING CLEANING THE INNER SIDE OF THE DOOR SURFACE WITH AN ALCOHOL THE TECHNICIAN CUT HIS FINGER ON A SHARP EDGE OF THE DOOR METAL PART. THE EDGE WAS KNIFE SHARP AND CUT THE BODY THROUGH THE TOWEL USED FOR CLEANING. THE TECHNICIAN NEEDED MEDICAL TREATMENT OF THE DEEP CUT WOUND IN INDEX FINGER - THE WOUND WAS GLUED. THE INJURY HAS BEEN CLASSIFIED AS SERIOUS AS MEDICAL INTERVENTION WAS NEEDED TO PRECLUDE LONG TERM CONSEQUENCES.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394500 46-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 46-4 0734015370031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention