BEUDAMED
    FDA Adverse Event Injury Summary report: N

    46-SERIES

    MDR report key: 22748452 · Received August 8, 2025

    Report

    Report Number
    9616031-2025-0000007
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    August 1, 2025
    Report Date
    August 8, 2025
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE HAS BEEN MADE AWARE OF AN INCIDENT INVOLVING A SERVICE ENGINEER EMPLOYED BY THE CUSTOMER, WHO SUSTAINED FACIAL BURNS WHILE PERFORMING MAINTENANCE ON OPERATIONAL EQUIPMENT. THE INVESTIGATION DETERMINED THAT THE ROOT CAUSE OF THE INCIDENT WAS THE TECHNICIAN¿S FAILURE TO FOLLOW THE EXPLICIT SAFETY PROCEDURES OUTLINED IN THE SERVICE MANUAL. THE MANUAL (PAGE 62, SECTION 5.1) CLEARLY REQUIRES THAT POWER, STEAM, AND WATER SUPPLIES BE SHUT OFF BEFORE PERFORMING ANY MAINTENANCE. DESPITE THIS REQUIREMENT, THE TECHNICIAN CHOSE TO CONDUCT MAINTENANCE WHILE THE EQUIPMENT REMAINED OPERATIONAL AND PRESSURIZED, WHICH DIRECTLY RESULTED IN THE RELEASE OF HOT WATER AND CAUSED THE INJURY. ACCORDING TO THE REPORT, THE EMPLOYEE SUSTAINED FACIAL BURNS CAUSED BY HOT WATER THAT SPRAYED OUT FROM INSIDE THE DEVICE. AT THE TIME OF THE EVENT, THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. THE DEVICE WAS DIRECTLY INVOLVED IN THE INCIDENT BUT WAS NOT OPERATING ACCORDING TO SPECIFICATION DUE TO LEAK AND THE TECHNICIAN¿S DEVIATION FROM REQUIRED MAINTENANCE PROCEDURES. BASED ON THE CURRENT INVESTIGATION, THERE IS NO EVIDENCE INDICATING ANY DEFICIENCY IN THE DESIGN, MANUFACTURING, OR PERFORMANCE OF THE DEVICE ON THE MARKET. THE INCIDENT WAS SOLELY THE RESULT OF NON-COMPLIANCE WITH MANDATORY SAFETY PROCEDURES BY THE CUSTOMER¿S SERVICE ENGINEER. AT THIS STAGE, NO FURTHER ACTION TOWARDS THE MANUFACTURING PROCESS OR MARKETED DEVICES IS WARRANTED. HOWEVER, GETINGE WILL CONTINUE TO CLOSELY MONITOR CUSTOMER FEEDBACK AND FIELD PERFORMANCE OF THE DEVICE FOR ANY FUTURE INFORMATION THAT MAY REQUIRE ADDITIONAL ACTION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    MANUFACTURER'S REFERENCE NUMBER: (B)(6).

    Description of Event or Problem · 0

    GETINGE HAS BEEN AWARE ABOUT THE AN INCIDENT INVOLVING A WORK ENGINEER WHO SUSTAINED INJURIES WHILE PERFORMING MAINTENANCE TASKS ON OPERATIONAL EQUIPMENT. ACCORDING TO THE REPORT, THE EMPLOYEE SUFFERED FACIAL BURNS CAUSED BY HOT WATER THAT SPRAYED OUT FROM INSIDE THE PRODUCT. THE INCIDENT OCCURRED WHILE THE ENGINEER WAS TIGHTENING A COMPONENT THAT HAD PREVIOUSLY BEEN IDENTIFIED AS LEAKING, AND THE EQUIPMENT WAS STILL IN OPERATION AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223820 46-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 46-4

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other