BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUNO OTN, SFC, EU

    MDR report key: 20864746 · Received December 6, 2024

    Report

    Report Number
    8010652-2024-0000099
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 19, 2024
    Report Date
    December 6, 2024
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. (B)(6). THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022.

    Additional Manufacturer Narrative · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE TABLE DID NOT RESPOND AND THERE WAS A SLIGHT SMELL POSSIBLY COMING FROM THE FRIED BOARD. THE PATIENT WAS ON THE TABLE WHEN THE ISSUE OCCURRED AND HAD TO BE MOVED TO ANOTHER OPERATING TABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, AND THUS WAS ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION OCCURRED, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATIONS. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR ISSUE OCCURRED. THE AFFECTED DEVICE WAS EVALUATED BY A GETINGE TECHNICIAN. THE BATTERIES 12V (2270054), THE CHARGER BOARD 1433 (31404501), THE COLUMN CONTROL UNIT 1433 (9706282), AND CU FOOT 1433 (9706392) WERE REPLACED. AFTER COMPLETING THE NECESSARY REPAIRS, THE TABLE WAS RECALIBRATED AND RETURNED TO SERVICE. THE TECHNICIAN SUSPECTED THAT A DIATHERMY MAY HAVE BEEN INVOLVED WHEN THE TABLE WAS NOT PROPERLY GROUNDED AND MAY HAVE SHORTED SOME BOARDS. ACCORDING TO THE INFORMATION PROVIDED FOLLOWING THE SERVICE VISIT ON SITE, NO SIGNS OF BURNING OR BURNT-OUT COMPONENTS WERE FOUND DURING THE INVESTIGATION OR REPAIR. BASED ON THE DATABASE REVIEW, THE BATTERIES WERE LAST REPLACED IN JANUARY 2022. THE CUSTOMER WAS ADVISED TO REPLACE THE BATTERIES DURING THE SERVICE VISIT IN NOVEMBER 2023, HOWEVER, THE PURCHASE ORDER FOR THE REPLACEMENT WAS NOT RAISED. THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE WAS CONTACTED TO ASSESS THE MOST PROBABLE ROOT CAUSE OF THE ISSUE. ACCORDING TO THE SME¿S EVALUATION, AFTER TWO YEARS AND NORMAL USE, THE BATTERIES SHOULD NOT HAVE AGED SO MUCH THAT THEY FAIL. EVEN IN CASE OF OLD BATTERIES, THE TABLE SHOULD STILL MOVE WHEN IT IS CONNECTED TO THE MAINS. IN ADDITION, THE SCENARIO RELATED TO A SHORTING OF THE COMPONENTS IN THE TABLE DUE TO A DIATHERMY TREATMENT IS UNLIKELY. HIGH-FREQUENCY TREATMENT MAY TEMPORARILY AFFECT THE TABLE, HOWEVER, THE TABLE MUST WORK AGAIN AFTERWARDS. BASED ON THE SME¿S STATEMENT, THE INFORMATION RECEIVED IS NOT SUFFICIENT TO GIVE A FINAL DIAGNOSIS OF A POSSIBLE ROOT CAUSE. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT THE INVESTIGATED ISSUE, NAMELY THE INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS IMPOSSIBLE TO DEFINE. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION REGARDING 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. INITIAL REPORTER: CLINICAL ENGINEER THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM FIELD DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE TABLE DID NOT RESPOND AND THERE WAS A SLIGHT SMELL POSSIBLY COMING FROM THE FRIED BOARD. THE PATIENT WAS ON THE TABLE WHEN THE ISSUE OCCURRED AND NEEDED TO BE MOVED TO ANOTHER OPERATING TABLE. FOLLOWING THE SERVICE VISIT ON SITE, IT WAS CONFIRMED THAT THE BATTERIES WERE FAULTY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE INABILITY TO POSITION THE PATIENT LEADING TO THE TRANSFER TO ANOTHER OPERATING TABLE AND POSSIBLY RESULTING IN PROCEDURAL DELAY, WAS TO REOCCUR. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE TABLE DID NOT RESPOND AND THERE WAS A SLIGHT SMELL POSSIBLY COMING FROM THE FRIED BOARD. THE PATIENT WAS ON THE TABLE WHEN THE ISSUE OCCURRED AND HAD TO BE MOVED TO ANOTHER OPERATING TABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - (B)(6). AS IT WAS STATED, THE TABLE DID NOT RESPOND AND THERE WAS A SLIGHT SMELL POSSIBLY COMING FROM THE FRIED BOARD. THE PATIENT WAS ON THE TABLE WHEN THE ISSUE OCCURRED AND NEEDED TO BE MOVED TO ANOTHER OPERATING TABLE. FOLLOWING THE SERVICE VISIT ON SITE, IT WAS CONFIRMED THAT THE BATTERIES WERE FAULTY. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE INABILITY TO POSITION THE PATIENT LEADING TO THE TRANSFER TO ANOTHER OPERATING TABLE AND POSSIBLY RESULTING IN PROCEDURAL DELAY, WAS TO REOCCUR.

    Description of Event or Problem · 0

    GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, THE TABLE DID NOT RESPOND AND THERE WAS A SLIGHT SMELL POSSIBLY COMING FROM THE FRIED BOARD. THE PATIENT WAS ON THE TABLE WHEN THE ISSUE OCCURRED AND HAD TO BE MOVED TO ANOTHER OPERATING TABLE. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE INABILITY TO POSITION THE TABLE AS REQUIRED DURING THE PROCEDURE, WAS TO REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515940 YUNO OTN, SFC, EU TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 143301B0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown