BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    88-SERIES

    MDR report key: 6479312 · Received April 11, 2017

    Report

    Report Number
    9616031-2017-00006
    Event Type
    Malfunction
    Date Received
    April 11, 2017
    Date of Event
    March 23, 2017
    Report Date
    October 25, 2017
    Manufacturer
    GETINGE DISINFECTION AB
    Product Code
    MEC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED BY THE MANUFACTURING SITE. EVALUATION OF THE DEVICE IS BEING PERFORMED 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 E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). GETINGE RECEIVED CUSTOMER COMPLAINT WHERE AS STATED SMOKE APPEARED ON THE BOTTOM OF 88-SERIES WASHER DISINFECTOR. IT WAS FOUND THAT IT WAS CAUSED BY THE WATER INPUT MODULE WHICH OVERHEATED. NO INJURY HAS BEEN REPORTED AS A RESULT OF THE DESCRIBED MALFUNCTION. THE EVENT TOOK PLACE WHEN THE DEVICE WAS IN PROCESS AND IT WAS DISCOVERED BY THE TECHNICIAN WHO WAS ON SITE TO PERFORMED REPAIR ON ANOTHER DEVICE. WHEN THE EVENT OCCURRED THE DEVICE WAS NOT USED FOR TREATMENT OR DIAGNOSIS. EVALUATION OF THE DEVICE HAS BEEN PERFORMED BY THE MANUFACTURER AT THE CUSTOMER SITE. CONCLUSION OF THE MANUFACTURER INVESTIGATION SHOWS THAT THE EVENT TOOK PLACE AS A COMBINATION OF TWO DIFFERENT FACTORS: INCORRECT PRESSURE SENSOR CALIBRATION SETTINGS. WRONG ADJUSTMENT OF THE DRAIN VALVE. AS IT WAS STATED BEFORE THE INCIDENT OCCURRED THE CPU BOARD ON THE DEVICE HAD BEEN REPLACED. AFTER THE REPLACEMENT OF THE CPU CALIBRATION OF PRESSURE SENSOR SHOULD BE PERFORMED. IT WAS CONCLUDED THAT MOST LIKELY THIS HAD NOT BEEN DONE. MOREOVER USER MANUAL FOR GETINGE 88-SERIES (6001234702, REV. G) INCLUDE INFORMATION THAT DIAPHRAGM DRAIN VALVE WHICH SHOULD BE CHECKED YEARLY AND REPLACED IF NECESSARY. FURTHERMORE IT ALSO INCLUDE CLEAR INFORMATION THAT THE DRAIN VALVE SHOULD BE CHECKED FOR THE LEAKS ONCE A MONTH. WE CONCLUDE FROM OUR INVESTIGATION THAT WHEN THE EVENT OCCURRED OUR DEVICE WAS NOT UP TO THE ORIGINAL SPECIFICATION, LOOKING AT ALL THE CIRCUMSTANCES WE BELIEVE THAT IF THE DEVICE HAD BEEN USED WITH CORRECT SETTINGS AND LIMITS THIS INCIDENT WOULD HAVE BEEN AVOIDED. IT APPEARS THERE HAS BEEN TECHNICAL DEFICIENCY WITH THE DEVICE WHICH WAS BEING USED AT THE TIME OF THE EVENT AND THAT POOR MAINTENANCE OF THE DEVICE WITH CONTRIBUTION TO WRONGLY PERFORMED REPAIR LED TO THE EVENT CAUSING THE DEVICE TO CONTRIBUTE TO THE OUTCOMES OF THIS EVENT. WHEN THE EVENT OCCURRED THE DEVICE WAS NOT USED FOR TREATMENT OR DIAGNOSIS AND DID NOT MEET ITS SPECIFICATION. THE DEVICE WHICH PLAYED ROLE IN THE REPORTED EVENT CONTRIBUTED TO THE OUTCOMES OF THE EVENT. WE REPORTED THIS CASE BASED ON INITIALLY INDICATION AND ABUNDANCE OF CAUTION, HOWEVER AFTER FURTHER EVALUATION WE WILL NOT DECIDE TO REPORT THIS CASE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). THE EVENT IS BEING INVESTIGATED 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 E2016015 BY THE MANUFACTURER GETINGE DISINFECTION AB, (REGISTRATION NO. 9616031) ON BEHALF OF THE IMPORTER GETINGE USA, INC., (REGISTRATION NO. 3004147784). ADDITIONAL INFORMATION WILL BE PROVIDED UPON RESULTS OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON (B)(6) GETINGE BECOME AWARE OF AN INCIDENT WHICH OCCURRED AT CUSTOMER SITE LOCATED IN (B)(6). AS IT WAS REPORTED BY THE CUSTOMER THAT DURING FINAL RINSE PHASE SMOKE APPEARED ON THE BOTTOM OF THE MACHINE. AT THE SAME TIME AND PLACE CUSTOMER STAFF WAS SERVICING OTHER MACHINE AND WHEN THE SMOKE APPEARED THE SERVICE PERSON HAS IMMEDIATELY STARTED TO SEARCH FOR A SOURCE OF SMOKE. IT HAS BEEN DISCOVERED AND REPORTED BY THE CUSTOMER STAFF THAT LOWER PART OF WATER INPUT MODULE CONNECTED TO THE CHAMBER BECAME VERY HOT CAUSING STAINLESS STEEL TO BECAME RED-HOT. IT CAUSED OVERHEATING OF THE CASING ISOLATION AND SEEMS THAT THE SMOKE EMITTED FROM HEATED ISOLATION. THE AMOUNT OF THE SMOKE WAS LIMITED, NO ALARM ACTIVATED, NO EVACUATION WAS PERFORMED, NO PERSON WAS INJURED. WE REPORT THIS CASE IN ABUNDANCE OF CAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264748 88-SERIES MEC MEC GETINGE DISINFECTION AB 88-5

    Patients

    Seq Age Sex Outcome Treatment
    1