BEUDAMED
    FDA Adverse Event Injury Summary report: N

    86-SERIES

    MDR report key: 17406848 · Received July 27, 2023

    Report

    Report Number
    3012092534-2023-00002
    Event Type
    Injury
    Date Received
    July 27, 2023
    Date of Event
    July 19, 2023
    Report Date
    September 6, 2024
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2023 GETINGE SERVICE WAS CALLED BY THE CUSTOMER FOR UNIT FAILED FOR ERROR CODE A01 MCB TRIP ON THE WASHER DISINFECTORS MODEL NAME 8668. THE TECHNICIAN INSPECTED THE DEVICE AND DISCOVERED THAT THE ERROR CODE A01 MCB TRIP WAS CAUSED BY MALFUNCTIONED CIRCULATION PUMP. AS IT WAS STATED IN THE INCIDENT DESCRIPTION THE CUSTOMER REMOVED THE LOWER PANEL BELOW THE DOOR AFTER UNIT HAD ERROR CODE. WHILE REMOVING PANEL, CUSTOMER CUT HIMSELF ON STAINLESS STEEL PANEL AND REQUIRED MEDICAL ATTENTION WHICH RESULTED IN APPLYING TWO STITCHES ON THE CUT HAND. BASED ON THE INFORMATION PROVIDED BY THE GETINGE TECHNICIAN THERE WAS NO APPARENT REASON WHY THE CUSTOMER THOUGHT THEY SHOULD TRY TO REMOVE THE PANEL - THERE ARE NO USER SERVICEABLE PARTS OR COMPONENTS FOR CUSTOMER TO ACCESS. GETINGE TECHNICIAN WAS UNSURE BUT THOUGHT THAT THE CUSTOMER WAS NOT WEARING ANY PROTECTIVE GEAR. WE BELIEVE THAT THE CUT INJURY WOULD HAVE BEEN AVOIDED IF THE SAFETY INSTRUCTIONS WERE FOLLOWED FOR THE MACHINE STATED IN SECTION 2.3 IN THE "SERVICE MANUAL OUTTAKE" WHERE IT TELLS THE OPERATOR TO WEAR PROTECTIVE GLOVES. SINCE THE CUSTOMER WASN´T A TRAINED TECHNICIAN AND BY THAT LOGIC COULD NOT HAVE KNOWN HOW TO FOLLOW SERVICE MANUAL INSTRUCTIONS, THE PERSON IN QUESTION SHOULD HAVE RESORTED TO THE "USER MANUAL 86 OUTTAKE", WHERE IT STATES: "INSTALLATION AND SERVICE WORK MUST BE PERFORMED ONLY BY TRAINED PERSONNEL." WE CATEGORIZE THAT INCIDENT AS A RESULT OF USER ERROR. IT WAS ESTABLISHED THAT THE GETINGE PRODUCT WAS DIRECTLY INVOLVED WITH THE REPORTED EVENT. WHEN THE INCIDENT OCCURRED, THE PRODUCT WAS DIRECTLY INVOLVED. THE DEVICE DID NOT MEET ITS SPECIFICATION. THE DEVICE WAS NOT BEING USED FOR TREATMENT OR DIAGNOSIS OF THE PATIENT. TREND REVIEW OF CUSTOMER PRODUCT COMPLAINTS WITH THE SAME ISSUE INVOLVED ON THIS TYPE OF DEVICES REPORTED WITHIN THE LAST 5 YEARS WAS PERFORMED BUT DID NOT PROVIDE ANY SIGNALS THAT TRIGGERED FURTHER SCRUTINY. WE BELIEVE THAT DEVICES IN THE MARKET ARE PERFORMING CORRECTLY OVERALL. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE.

    Description of Event or Problem · 0

    ON 19TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE RELATED TO THE WASHER DISINFECTORS WITH THE MODEL NAME 8668. AS IT WAS STATED CUSTOMER REMOVED THE LOWER PANEL BELOW THE DOOR AFTER AN ERROR CODE APPEARED. WHILE REMOVING THE STAINLESS STEEL PANEL THE CUSTOMER CUT HIMSELF AND REQUIRED MEDICAL ATTENTION. THE INJURY WAS CLASSIFIED AS SERIOUS AS TWO STITCHES WERE NEEDED ON THE CUT HAND.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755584 86-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 8668

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention