BEUDAMED
    FDA Adverse Event Injury Summary report: N

    86-SERIES

    MDR report key: 11912490 · Received June 1, 2021

    Report

    Report Number
    3012092534-2021-00001
    Event Type
    Injury
    Date Received
    June 1, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 23, 2021
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN INCIDENT WHICH HAPPENED DURING A REPAIR OF 8668 WASHER DISINFECTOR. AS IT WAS STATED, WHILE REPAIRING THE DEVICE, THE TECHNICIAN SUSTAINED A SERIOUS INJURY DESCRIBED THUMB LACERATION REQUIRED MEDICAL INTERVENTION BY USING SEVERAL STITCHES TO SECURE THE WOUND. THE DEVICE INVOLVED IN THE INCIDENT HAS BEEN IDENTIFIED AS A 8666 WASHER DISINFECTOR WITH SERIAL NUMBER: (B)(6). THE UNIT WAS MANUFACTURED ON 5TH FEBRUARY, 2014. THE EVENT SCENARIO HAS BEEN DEFINED AS SINGLE ISOLATED ONE ON 86-SERIES DEVICES. DURING THE INVESTIGATION COURSE WE WERE ABLE TO ESTABLISH, THAT THE SERVICE TECHNICIAN WENT TO THE CUSTOMER FACILITY TO REPAIR THE GETINGE DEVICE. TO REACH THE TOP OF THE UNIT TO REPLACE MALFUNCTIONED PART, HE HAD TO USE THE LADDER. THE LADDER BROKE WHILE THE TECHNICIAN WAS STANDING ON IT AND TO AVOID FALLING HE GRABBED THE METAL SHEET PLACED ON THE WALL OVER THE DEVICE. AT THE TIME OF THE INCIDENT THE DEVICE WAS NOT UP TO THE MANUFACTURER SPECIFICATION, HOWEVER BASED ON THE INCIDENT SCENARIO WE CAN CONCLUDE THAT THE CAUSE OF THE INJURY WAS NOT DIRECTLY RELATED TO THE GETINGE DEVICE BUT WAS CAUSED BY THE PART OF THE FACILITY CONSTRUCTION.. NEVERTHELESS, IN THE SERVICE MANUAL FOR 86-SERIES DEVICES (DOC NO. 6002009602, REV. H) IN CHAPTER 2.3 IT IS STATED, THAT THE TECHNICIAN PERFORMING THE REPAIR OF THE DEVICE SHOULD ALWAYS WEAR PROTECTIVE GLOVES, WHICH TECHNICIAN DID NOT HAVE. TO SUM UP, THE ROOT CAUSE OF AN EVEN WAS DEFINED AS A COMBINATION OF SEVERAL FACTORS: BROKEN LADDER, FACILITY ISSUES AND NOT FOLLOWING THE INSTRUCTIONS REGARDING PROTECTING GLOVES. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE GETINGE DEVICE WAS NOT DIRECTLY INVOLVED IN THE DESCRIBED INCIDENT. NONE OF THE PROVIDED INFORMATION INDICATES THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. 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. THERE IS ALSO A CORRECTION OF 'MANUFACTURE DATE' (H4) FIELD DUE TO DHR DOCUMENT REVIEW: OLD H4: 2/11/2014; CORRECTED H4: 02/05/2014.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON 19TH MAY, 2021 GETINGE BECAME AWARE OF AN ISSUE RELATED TO 8668 WASHER DISINFECTOR. AS IT WAS STATED, WHILE REPAIRING THE DEVICE, THE TECHNICIAN SUSTAINED THUMB LACERATION REQUIRED SEVERAL STITCHES TO SECURE THE WOUND. THE INJURY WAS CLASSIFIED AS SERIOUS AS THE MEDICAL INTERVENTION WAS NEEDED. COMPLAINT-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809643 86-SERIES DISINFECTOR, MEDICAL DEVICES MEC GETINGE DISINFECTION AB 8668

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention