BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ES60

    MDR report key: 7905518 · Received September 25, 2018

    Report

    Report Number
    3012068831-2018-00011
    Event Type
    Malfunction
    Date Received
    September 25, 2018
    Date of Event
    August 28, 2018
    Report Date
    October 22, 2018
    Manufacturer
    GETINGE IC PRODUCTION POLAND SP. Z.O.O.
    Product Code
    FLE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. 3012092534). WHEN REVIEWING REPORTABLE EVENTS FOR THIS TYPE OF ISSUES WE WERE ABLE TO ESTABLISH THAT RECEIVED INCIDENT IS THE FIRST ONE REGISTERED IN GETINGE COMPLAINT HANDLING SYSTEM FOR STAND-ALONE TYPE OF BOILER, MODEL NUMBER ES60. THE ISSUE IS CONSIDERED TO BE A SINGLE, ISOLATED EVENT. ON (B)(6) 2018 WE BECAME AWARE OF AN INCIDENT WITH BOILER ES60 CONNECTED TO 233HC STERILIZER. AS IT WAS STATED BY TECHNICIAN, THE SPARKS AND BURNING SMELL WAS COMING FROM THE BOILER. NO ADVERSE OUTCOME WAS REPORTED. ALTHOUGH THE BOILER ITSELF IS NOT REGISTERED AS A MEDICAL DEVICE IT IS CONNECTED TO A MEDICAL DEVICE AND COULD BE CONSIDERED AS PART OF A MEDICAL DEVICE SYSTEM. HAVING THIS IN MIND, WE DECIDED TO REPORT THIS COMPLAINT IN ABUNDANCE OF CAUTION AND BASED ON THE POTENTIAL OF OVERHEATING OF THE DEVICE. AFTER THE ISSUE OCCURRENCE, THE DEVICE HAS BEEN INSPECTED BY GETINGE TECHNICIAN AND DESCRIBED AS UNREPAIRABLE, THUS EXCLUDED FROM THE SERVICE. THE BOILER INVOLVED IN THE EVENT WAS IDENTIFIED AS ES60 STAND-ALONE TYPE OF BOILER MANUFACTURED BY SUSSMAN, WITH SERIAL NUMBER ESM1131963-016. THOSE TYPE OF DEVICES, ALTHOUGH NOT MANUFACTURED BY GETINGE ARE SOLD BY OUR COMPANY AS A COMPLEMENTARY UNIT AND CONNECTED VIA PIPE TO THE GETINGE LABELED STERILIZER OR WASHER. BASED ON THE INFORMATION COLLECTED TO DATE AND AS A RESULT OF PERFORMED INVESTIGATION IT HAS BEEN CONFIRMED THAT WHEN THE DEVICE IS NOT WELL MAINTAINED, THE HEATING ELEMENTS CAN LEAK WATER INTO ELECTRICAL CABINET, RESULTING IN THE SITUATION AS DESCRIBED WITHIN THIS INCIDENT. ACCORDING TO SUSSMAN ELECTRICAL BOILERS ES&HU INSTALLATION, OPERATION AND MAINTENANCE MANUAL PUR 101137 REV 5.18 PAGE 13 THE INTERNAL WIRING SHOULD BE INSPECTED ONCE A MONTH AND IF ANY WIRE SHOWS SIGNS OF DAMAGE, IT SHOULD BE REPLACED. WHAT IS MORE, ALL HEATING ELEMENTS MOUNTING BOLTS SHOULD BE CHECKED AND TIGHTENED TO A TORQUE OF 22 FT.-LBS. IF THERE ARE SIGNS OF STEAM LEAKS, GASKET SHOULD BE REPLACED. ALL ELEMENTS SHOULD BE ALSO CHECKED FOR LEAK ONCE A MONTH AND IF ANY PART IS DAMAGED IT SHOULD BE REPLACED. IN SUMMARY, WHEN THE EVENT OCCURRED, THE BOILER DEVICE LIKELY DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. UPON THE EVENT OCCURRENCE THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT. WE BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. 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 AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. ADDITIONALLY, THE INFORMATION REGARDING THE INCIDENT HAS BEEN FORWARDED TO THE ORIGINAL MANUFACTURER OF THE BOILER DEVICE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2017051 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE GROUP LOGISTICS AMERICA, LLC, (REGISTRATION NO. 3012092534). THE ISSUE IS UNDER MANUFACTURER'S ANALYSIS.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE NUMBER (B)(4).

    Description of Event or Problem · 0

    ON (B)(6) 2018 WE BECAME AWARE OF AN INCIDENT WITH BOILER ES60 WHICH WAS CONNECTED TO 233HC DEVICE. AS IT WAS STATED BY TECHNICIAN, THE SPARKS AND BURNING SMELL WAS COMING FROM BOILER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION, ALTHOUGH THE BOILER IS NOT A MEDICAL DEVICE ITSELF BUT IS CONNECTED TO MEDICAL DEVICE AND COULD BE CONSIDERED AS A SYSTEM, BASED ON THE POTENTIAL OF OVERHEATING OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747514 ES60 ES60 FLE GETINGE IC PRODUCTION POLAND SP. Z.O.O. ES 60

    Patients

    Seq Age Sex Outcome Treatment
    1