BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GSS67

    MDR report key: 12598213 · Received October 8, 2021

    Report

    Report Number
    8010652-2021-00028
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 9, 2021
    Report Date
    November 5, 2021
    Manufacturer
    MAQUET GMBH
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH GSS67H STEAM STERILIZER. AS IT WAS STATED, DURING THE REPAIR OF DEVICE WHICH HAD PROBLEM WITH VACUUM TIMEOUT ALARM, SERVICE TECHNICIAN BURNED HIS HAND ON AN UNINSULATED STEAM PIPE TO THE JACKET ON THE MACHINE. THE SUSTAINED BURN DID NOT REQUIRE A MEDICAL INTERVENTION, THUS WAS NOT CLASSIFIED AS A SERIOUS ONE. HOWEVER IT WAS DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS THE SCENARIO DESCRIBED COULD LEAD TO SERIOUS INJURY OR WORSE AND BASED ON THE SIMILARITY OF MODELS BETWEEN GSS67H AND GSS67N. SERVICE WAS COMPLETED AND DEVICE WAS RETURNED TO USAGE. WITH THE INFORMATION RECEIVED, WE CONCLUDE THAT THE GETINGE DEVICE DID MEET ITS SPECIFICATION BUT IT CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT AT THE TIME WHEN THE EVENT OCCURRED. WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT THE RECEIVED INCIDENT IS THE FIRST ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEMS. FORTUNATELY, THE EVENT HAS NOT LED TO SERIOUS INJURY OR WORSE. THE CASE WAS ANALYZED BY THE SUBJECT MATTER EXPERT. IT WAS CONCLUDED THAT THERE IS A TECHNICAL/PROCESS RELATED REASON FOR NOT HAVING THIS PIPE INSULATED AND THAT THE TECHNICIAN IN QUESTION IS CERTIFIED ON THE GSS67 AND IN THAT CASE SHOULD BE AWARE OF THE HAZARDS CONNECTED TO SERVICING THE UNIT. BASED ON OUR ANALYSIS, GETINGE ESTABLISHED THE MOST LIKELY ROOT CAUSE TO BE RELATED TO THE SERVICE. WARNINGS ABOUT HAZARDS, POSSIBLE IN THE SERVICE AREA, ARE INCLUDED IN THE SERVICE MANUAL AND CERTIFIED TECHNICIANS SHALL BE AWARE OF IT. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE DEVICES, HOWEVER AS PER OUR COMPLAINT HANDLING PROCESSES WILL CONTINUE TO MONITOR THE CUSTOMER EXPERIENCES WITH THE DEVICE FOR ANY FUTURE INFORMATION. THE PURPOSE OF THIS SUBMISSION IS ALSO TO PROVIDE A CORRECTION OF FIELD #H6 MEDICAL DEVICE - PROBLEM CODE. THIS IS BASED ON THE RESULT OF AN INTERNAL REVIEW. PREVIOUS #H6 MEDICAL DEVICE - PROBLEM CODE: 3189. CORRECTED #H6 MEDICAL DEVICE - PROBLEM CODE: 2993 AND 2017.

    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 MANUFACTURING SITE.

    Description of Event or Problem · 1

    ON (B)(6) 2021 GETINGE BECAME AWARE OF AN ISSUE WITH GSS67H STEAM STERILIZER. AS IT WAS STATED, DURING THE REPAIR OF DEVICE WHICH HAD PROBLEM WITH VACUUM TIMEOUT ALARM, SERVICE TECHNICIAN BURNED HIS HAND ON AN UNINSULATED STEAM PIPE TO THE JACKET ON THE MACHINE. THE SUSTAINED BURN DID NOT REQUIRE A MEDICAL INTERVENTION, THUS WAS NOT CLASSIFIED AS A SERIOUS ONE. WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL AS IT COULD LEAD TO SERIOUS INJURY OR WORSE AND BASED ON THE SIMILARITY OF MODELS BETWEEN GSS67H AND GSS67N.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493451 GSS67 STERILIZER, STEAM FLE MAQUET GMBH GSS67H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other