BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUNO OTN, SFC, EU

    MDR report key: 19104245 · Received April 15, 2024

    Report

    Report Number
    8010652-2024-00055
    Event Type
    Malfunction
    Date Received
    April 15, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 15, 2024
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1H EVENT SITE POSTAL CODE: (B)(6). E1I EVENT SITE TELEPHONE: (B)(6).

    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, AN UNINTENDED DOWN MOVEMENT OF THE BOTTOM END OF THE TABLE OCCURRED DURING THE FEMORAL NAILING PROCEDURE. THE MOTION WAS QUICK BUT GRADUAL AND LED TO A CHANGE IN THE PATIENT¿S POSITION. DUE TO THE ISSUE, THE STAFF HAD TO TRANSFER THE ANESTHETIZED PATIENT ONTO A TROLLEY AND THEN, AFTER PREPARATION, TO ANOTHER TABLE. AS A RESULT, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED MOVEMENT LEADING TO A CHANGE IN THE POSITION OF THE PATIENT AND DELAY RELATED TO THE TRANSFER OF THE PATIENT TO ANOTHER OPERATING TABLE DURING THE PROCEDURE, WAS TO REOCCUR. THE AFFECTED DEVICE WAS EVALUATED BY A GETINGE TECHNICIAN. A CHECK OF THE HYDRAULIC PRESSURE WAS CARRIED OUT AND THE LEAK WAS CONFIRMED. 5202784 DOUBLE CHECK VALVE (USABLE TILL/HERION) AND 17020019 O-RING DIN3771- 5X1,5-N-NBR70 WERE REPLACED AND THE UNIT WAS RETURNED TO SERVICE. HOWEVER, AFTER THE REPAIR, THE FAULT REAPPEARED. FOLLOWING THE REPLACEMENT OF 5207240 HYDRAULIC UNIT COLUMN AND 17020929 O-RING DIN3771-10X1,5-N-NBR70, THE ISSUE WAS RESOLVED. 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 INJURIES TO A USER NOR TO A PATIENT OR OPERATOR WHEN THIS PARTICULAR INCIDENT OCCURRED. 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, THE HYDRAULIC OIL CAN BECOME CONTAMINATED DUE TO ABRASION IN THE SYSTEM. THIS CONTAMINATION OF THE OIL MAY IMPAIR THE CLOSING AND TIGHTNESS OF THE DOUBLE CHECK VALVE. A LEAK IN 5207240 HYDRAULIC UNIT COLUMN WILL BE THE CONSEQUENCE OF THIS ISSUE. SLOW SINKING OF THE CYLINDER IS POSSIBLE DUE TO THE SMALL GAP OF THE DIRTY VALVE. DURING MAINTENANCE, THE CONTAMINATED OIL SHOULD BE REPLACED WITH NEW OIL BEFORE DAMAGE OCCURS. ACCORDING TO THE PROVIDED INFORMATION, THE HOSPITAL¿S ELECTRICAL AND BIOMEDICAL ENGINEERING TEAM IS RESPONSIBLE FOR THE MAINTENANCE. THE USER IS INFORMED IN THE INSTRUCTIONS FOR USE (GA 1433.01 EN 08 P.118) THAT THE MAINTENANCE MUST BE PERFORMED EVERY 2 YEARS AND, AS OF THE 5TH YEAR, EVERY YEAR TO ENSURE SAFE OPERATION OF THE PRODUCT. AS DESCRIBED IN THE MAINTENANCE MANUAL (TW 1433.01 EN 04 P. 46-47), THE OIL TANK OF THE HYDRAULIC UNIT FOR THE COLUMN SHOULD BE REMOVED AND THE POLLUTED OIL REPLACED DURING PREVENTIVE MAINTENANCE. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT BASED ON AVAILABLE INFORMATION THE MOST PROBABLE ROOT CAUSE OF THE REPORTED ISSUE, NAMELY THE UNINTENDED MOVEMENT LEADING TO CHANGE IN THE POSITION OF THE PATIENT AND DELAY RELATED TO THE TRANSFER OF THE PATIENT TO ANOTHER OPERATING TABLE DURING THE PROCEDURE, WAS USER ERROR RELATED TO INADEQUATE MAINTENANCE. 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. THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE 09/24/2022. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D4 SERIAL #, H4 DEVICE MANUFACTURE DATE AND H6 HEALTH EFFECT ¿ IMPACT CODES FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 29TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, AN UNINTENDED DOWN MOVEMENT OF THE BOTTOM END OF THE TABLE OCCURRED DURING THE FEMORAL NAILING PROCEDURE. THE MOTION WAS QUICK BUT GRADUAL AND LED TO A CHANGE IN THE PATIENT¿S POSITION. DUE TO THE ISSUE, THE STAFF HAD TO TRANSFER THE ANESTHETIZED PATIENT ONTO A TROLLEY AND THEN, AFTER PREPARATION, TO ANOTHER TABLE. AS A RESULT, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. ACCORDING TO INFORMATION PROVIDED BY GETINGE TECHNICIAN FOLLOWING SERVICE VISIT ON SITE, THE HYDRAULIC LEAK WAS CONFIRMED AND REPLACEMENT OF TREND 5/3 RETURN VALVE IS REQUIRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED MOVEMENT LEADING TO CHANGE IN THE POSITION OF THE PATIENT AND DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, 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, AN UNINTENDED DOWN MOVEMENT OF THE BOTTOM END OF THE TABLE OCCURRED DURING THE FEMORAL NAILING PROCEDURE. THE MOTION WAS QUICK BUT GRADUAL AND LED TO A CHANGE IN THE PATIENT¿S POSITION. DUE TO THE ISSUE, THE STAFF HAD TO TRANSFER THE ANESTHETIZED PATIENT ONTO A TROLLEY AND THEN, AFTER PREPARATION, TO ANOTHER TABLE. AS A RESULT, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED MOVEMENT LEADING TO A CHANGE IN THE POSITION OF THE PATIENT AND DELAY RELATED TO THE TRANSFER OF THE PATIENT TO ANOTHER OPERATING TABLE DURING THE PROCEDURE, WAS TO REOCCUR. PREVIOUS D4 SERIAL #: (B)(6). CORRECTED D4 SERIAL #: (B)(6). PREVIOUS H4 DEVICE MANUFACTURE DATE: 10/01/2016. CORRECTED H4 DEVICE MANUFACTURE DATE: 08/23/2016. PREVIOUS H6 HEALTH EFFECT ¿ IMPACT CODES: SURGICAL INTERVENTION/PROLONGED SURGERY//4632. CORRECTED H6 HEALTH EFFECT ¿ IMPACT CODES: DELAY TO TREATMENT/ THERAPY///4604.

    Description of Event or Problem · 0

    ON 29TH MARCH 2024, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 143301B0 - YUNO OTN, SFC, EU. AS IT WAS STATED, AN UNINTENDED DOWN MOVEMENT OF THE BOTTOM END OF THE TABLE OCCURRED DURING THE FEMORAL NAILING PROCEDURE. THE MOTION WAS QUICK BUT GRADUAL AND LED TO A CHANGE IN THE PATIENT¿S POSITION. DUE TO THE ISSUE, THE STAFF HAD TO TRANSFER THE ANESTHETIZED PATIENT ONTO A TROLLEY AND THEN, AFTER PREPARATION, TO ANOTHER TABLE. AS A RESULT, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. ACCORDING TO INFORMATION PROVIDED BY GETINGE TECHNICIAN FOLLOWING SERVICE VISIT ON SITE, THE HYDRAULIC LEAK WAS CONFIRMED AND REPLACEMENT OF TREND 5/3 RETURN VALVE IS REQUIRED. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED MOVEMENT LEADING TO CHANGE IN THE POSITION OF THE PATIENT AND DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, 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, AN UNINTENDED DOWN MOVEMENT OF THE BOTTOM END OF THE TABLE OCCURRED DURING THE FEMORAL NAILING PROCEDURE. THE MOTION WAS QUICK BUT GRADUAL AND LED TO A CHANGE IN THE PATIENT¿S POSITION. DUE TO THE ISSUE, THE STAFF HAD TO TRANSFER THE ANESTHETIZED PATIENT ONTO A TROLLEY AND THEN, AFTER PREPARATION, TO ANOTHER TABLE. AS A RESULT, THE PROCEDURE WAS DELAYED BY APPROXIMATELY 30 MINUTES. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IF THE SITUATION, NAMELY THE UNINTENDED MOVEMENT LEADING TO A CHANGE IN THE POSITION OF THE PATIENT AND DELAY RELATED TO THE TRANSFER OF THE PATIENT TO ANOTHER OPERATING TABLE DURING THE PROCEDURE, WAS TO REOCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837853 YUNO OTN, SFC, EU TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 143301B0

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown