BEUDAMED
    FDA Adverse Event Injury Summary report: N

    533HC

    MDR report key: 7082670 · Received December 5, 2017

    Report

    Report Number
    3012068831-2017-00001
    Event Type
    Injury
    Date Received
    December 5, 2017
    Date of Event
    November 10, 2017
    Report Date
    May 2, 2018
    Manufacturer
    GETINGE IC PRODUCTION POLAND SP. Z.O.O.
    Product Code
    FLE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016014 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O. ON (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016014 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. (B)(4)). THE EVENT IS STILL BEING EVALUATED BY THE MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016014 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. (B)(4)) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. (B)(4)). GETINGE RECEIVED A CUSTOMER COMPLAINT WITH ALLEGATION ABOUT INJURY CAUSED BY THE STEAM RELEASED FROM THE CHAMBER DURING DOOR OPENING. INVESTIGATION WAS PERFORMED ON THIS ISSUE. IT HAS BEEN ESTABLISHED THAT THERE IS NO TREND FOR THIS KIND OF FAILURE. INJURY WHICH WAS A RESULT OF COMPLAINED EVENT HAS BEEN RECOGNIZED AS 1ST DEGREE BURN ON OPERATOR'S FACE AND NECK. OPERATOR MANUAL (61301608208, REV. C) FOR 400HC/500 HC STEAM STERILIZERS WHICH WAS CURRENT AT THE TIME WHEN THE AFFECTED DEVICE WAS MANUFACTURED INCLUDES PROPER WARNINGS WHICH ALLOWS TO MINIMALIZE THE RISK RELATED TO THE HOT STEAM RELEASE. IT CLEARLY STATES THAT THE CHAMBER AND JACKET PRESSURE GAUGES SHOULD BE OBSERVED WHILE THE STEAM BLEEDS FROM THE CHAMBER. THE OPERATOR SHOULD WAIT UNTIL THE PRESSURE IS AT ZERO (0 PSIG) BEFORE OPERATING HE HAND VALVE AS HOT STEAM CAN CAUSE SERIOUS INJURY. IT ALSO STATES THAT:"DO NOT ATTEMPT TO OPEN THE STERILIZER CHAMBER DOOR UNLESS THE CHAMBER PRESSURE GAUGE READS ZERO (0 PSIG)". MOREOVER, IT INCLUDES INFORMATION ABOUT TECHNIQUES FOR UNLOADING THE STERILIZER (PAGE 4-8) - BURN HAZARD INFORMATION. "BEFORE REMOVING A LOAD FROM THE CHAMBER, MANUALLY LOWER THE DOOR APPROXIMATELY ONE INCH TO ALLOW RESIDUAL STEAM TO ESCAPE. (IF THE STERILIZER HAS A POWER DOOR, UNSEAL THE DOOR AND WAIT ABOUT A MINUTE FOR THE STEAM TO VENT BEFORE OPENING THE DOOR.) STAND BACK TO AVOID POSSIBLE BURNS WHEN LOWERING THE DOOR." BASED ON THE TECHNICAL KNOWLEDGE OF THE CURRENT MANUFACTURER IT HAS BEEN ESTABLISHED THAT FAILED STEAM VALVE MUST HAVE PASSED UP THE STEAM INTO THE CHAMBER WHICH RESULTED IN THE NON-SIGNIFICANT PRESSURE INCREASE. TAKING UNDER CONSIDERATION ALL COLLECTED INFORMATION IT COULD BE CONCLUDED THAT THE ISSUE OCCURRED MOST PROBABLY DUE TO COMBINATION OF TWO FACTORS: A FAILURE OF STEAM VALVE THAT ALLOWED A STEAM INTO THE CHAMBER AND USER ERROR, WHO DID NOT FOLLOW SAFETY INSTRUCTIONS INCLUDED IN OPERATOR MANUAL AND OPENED THE DOOR WITHOUT CHECKING THE CHAMBER AND JACKET PRESSURE GAUGES. IN SUMMARY, WHEN THE EVENT OCCURRED, THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT OR DIAGNOSIS. IT WAS NOT UP TO SPECIFICATION AND IT CONTRIBUTED TO THE OUTCOMES OF THE EVENT. GIVEN THE CIRCUMSTANCES AND THE FACT THAT COMPLAINT WAS FOUND TO BE A SINGLE, ISOLATED INCIDENT WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016014 BY THE MANUFACTURER GETINGE IC PRODUCTION POLAND SP. Z.O.O, (REGISTRATION NO. 3012068831) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) WE BECOME AWARE OF AN INCIDENT WHERE ONE OF OUR 533HC STEAM STERILIZER WAS INVOLVED. AS STATED BY THE CUSTOMER THE STERILIZER'S OPERATOR HAD TO RUN BOWI DICK TEST ON THE DEVICE. DUE TO THIS THERE WAS A NEED OF DOOR OPENING. WHEN THE OPERATOR OPENED THE DOOR, THE STEAM ESCAPED FROM THE CHAMBER AND HIT THE OPERATOR IN THE FACE. IT CAUSED BURN ON OPERATOR'S FACE AND NECK. SO FAR WE DO NOT HAVE INFORMATION HOW SEVER WAS THIS BURN, HOWEVER WE DECIDED TO REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016014 (B)(4). THE EVENT IS BEING INVESTIGATED BY THE MANUFACTURING SITE. ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864379 533HC FLE FLE GETINGE IC PRODUCTION POLAND SP. Z.O.O. 533HC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other