UNIVERSAL TABLE TOP, SFC, EU
Report
- Report Number
- 8010652-2023-00019
- Event Type
- Malfunction
- Date Received
- March 14, 2023
- Date of Event
- February 23, 2023
- Report Date
- January 25, 2024
- Manufacturer
- MAQUET GMBH
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. EVENT SITE NAME: (B)(6). DEVICE NOT RETURNED TO MANUFACTURER.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED IN COMBINATION WITH 116045BC CARBON FIBRE INSERTABLE PLATE (SHORT),116045AC CARBON FIBRE INSERTABLE PLATE (LONG) AND 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. AS IT WAS STATED, THERE WAS A LARGE PLAY AT THE CONNECTION BETWEEN TABLE TOP AND ACCESSORIES (UP TO 5 CM) WHICH MAY POTENTIALLY HAVE LED TO FAST UNINTENDED MOVEMENT DURING SURGERIES PERFORMED ON CHILDREN. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS DETECTED DURING INITIAL USE. IT WAS CLARIFIED WITH THE TECHNICIAN THAT THE PROBLEM EXISTS IN COMBINATION OF 116010B0 - UNIVERSAL TABLE TOP, SFC, EU WITH 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. NO SPECIFIC INCIDENT OR INJURY WAS REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IN CASE THE DEVICE IS USED IN CHILDREN'S PROCEDURE AND FAST UNINTENDED MOVEMENT DUE TO PLAY ON HANGING POINTS OCCURS, LEADING TO CHANGE IN THE PATIENT'S POSITION. RECENTLY, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN. THE AFFECTED GETINGE DEVICES HAVE BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN AND THE MEASUREMENTS PERFORMED ACCORDING TO THE GUIDELINES OF THE MANUFACTURER. IT WAS REVEALED THAT THE MEASURES WERE IN THE TOLERANCE RANGE AND THE DEVICE WORKED ACCORDING TO ITS SPECIFICATION, THEREFORE THE CLINICAL EXPERT REEVALUATED THE RISK RELATED TO THE ISSUE INVESTIGATED HEREIN AND ASSESSED AS NON-SAFETY NOR RISK-RELATED ISSUE AS THE PLATE CANNOT MOVE DRASTICALLY AS A RESULT AND THE PATIENT IS NOT ENDANGERED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. WITH THE INVESTIGATION PERFORMED IT WAS CONCLUDED THAT UPON THE EVENT OCCURRENCE, THE DEVICE WAS BEING USED FOR THE PATIENT¿S TREATMENT, BUT WAS NOT DIRECTLY INVOLVED WITH ANY ADVERSE EVENT. AS NO MALFUNCTIONS WERE FOUND, IT WAS CONSIDERED THAT THE GETINGE DEVICE WAS UP TO THE SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT THERE WERE NO SERIOUS INJURIES TO A USER NOR A PATIENT OR OPERATOR WHEN THIS PARTICULAR MALFUNCTION OCCURRED. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF THE 116010X0 - UNIVERSAL TABLE TOP PLACED ON THE MARKET WE CAN CONCLUDE THE FAILURE RATIO IS 0,27% AS THERE WERE TWO SIMILAR NON-REPORTABLE CUSTOMER PRODUCT COMPLAINTS. COMPARING THE NUMBER OF COMPLAINED DEVICES TO THE NUMBER OF THE 116010X0 - UNIVERSAL TABLE TOP, 116045BC CARBON FIBRE INSERTABLE PLATE (SHORT),116045AC CARBON FIBRE INSERTABLE PLATE (LONG) AND 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET (WE CAN CONCLUDE THE FAILURE RATIO IS 0,19% FOR THIS PARTICULAR CONFIGURATION. THE ROOT CAUSE EVALUATION WAS PERFORMED BY THE SUBJECT MATTER EXPERT (SME) AT THE MANUFACTURING SITE BASED ON THE MEASUREMENTS TAKEN BY THE SERVICE TECHNICIAN. ACCORDING TO THE SME, THE BEHAVIOR OF THE DEVICE THAT WAS COMPLAINED BY THE CUSTOMER IS NORMAL. MOREOVER, THE MOUNTING INTERFACE ON THE TABLE TOP IS DESIGNED IN SUCH A WAY THAT THE ACCESSORIES (FOR EXAMPLE 116059 OR 116045) THAT ARE ATTACHED OR SUSPENDED THERE CAN BE ADAPTED WITHOUT GREAT EFFORT OR ADDITIONAL ACTUATION OF OPERATING ELEMENTS (CLAMPING SCREWS, ETC.). THE SME ALSO EMPHASIZED THAT A CERTAIN AMOUNT OF PLAY IS NORMAL AND DEPENDS ON THE POSITION (LENGTH) AT WHICH IT IS MEASURED. MOREOVER, THE SUBJECT MATTER EXPERT POINTED OUT THAT AS SOON AS A PATIENT IS POSITIONED ON THE SUPPORT PLATE, THE FRICTION OCCURS AND THE WOBBLE IS ELIMINATED. IN SUMMARY AND AS A RESULT OF THE PERFORMED ROOT CAUSE EVALUATION, IT WAS CONCLUDED THAT THERE WAS NO FAULT WITH THE DEVICES AND THE ROOT CAUSE OF THIS ISSUE IS NOT CONFIRMED. WE CURRENTLY DO NOT HAVE ANY INFORMATION THAT WOULD WARRANT FURTHER ACTION TOWARDS THE 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. E1H EVENT SITE POSTAL CODE: 8036 THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D11 CONCOMITANT PRODUCTS, E1B EVENT SITE NAME, H4 DEVICE MANUFACTURE DATE AND H6 MEDICAL DEVICE ¿ PROBLEM CODE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 23RD FEBRUARY 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED IN COMBINATION WITH 116045BC CARBON FIBRE INSERTABLE PLATE (SHORT),116045AC CARBON FIBRE INSERTABLE PLATE (LONG) OR 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. AS IT WAS STATED, THERE IS A LARGE PLAY AT THE CONNECTION BETWEEN TABLE TOP AND ACCESSORIES (UP TO 5 CM) WHICH MAY POTENTIALLY LEAD TO FAST UNINTENDED MOVEMENT DURING SURGERIES PERFORMED ON CHILDREN. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS DETECTED DURING INITIAL USE. NO SPECIFIC INCIDENT OR INJURY WAS REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IN CASE THE DEVICE IS USED IN CHILDREN'S PROCEDURE AND FAST UNINTENDED MOVEMENT DUE TO PLAY ON HANGING POINTS OCCURS, LEADING TO CHANGE IN THE PATIENT'S POSITION. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 23RD FEBRUARY 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED IN COMBINATION WITH 116045BC CARBON FIBRE INSERTABLE PLATE (SHORT),116045AC CARBON FIBRE INSERTABLE PLATE (LONG) AND 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. AS IT WAS STATED, THERE WAS A LARGE PLAY AT THE CONNECTION BETWEEN TABLE TOP AND ACCESSORIES (UP TO 5 CM) WHICH MAY POTENTIALLY HAVE LED TO FAST UNINTENDED MOVEMENT DURING SURGERIES PERFORMED ON CHILDREN. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS DETECTED DURING INITIAL USE. IT WAS CLARIFIED WITH THE TECHNICIAN THAT THE PROBLEM EXISTS IN COMBINATION OF 116010B0 - UNIVERSAL TABLE TOP, SFC, EU WITH 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. NO SPECIFIC INCIDENT OR INJURY WAS REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IN CASE THE DEVICE IS USED IN CHILDREN'S PROCEDURE AND FAST UNINTENDED MOVEMENT DUE TO PLAY ON HANGING POINTS OCCURS, LEADING TO CHANGE IN THE PATIENT'S POSITION. RECENTLY, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN. THE AFFECTED GETINGE DEVICES HAVE BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN AND THE MEASUREMENTS PERFORMED ACCORDING TO THE GUIDELINES OF THE MANUFACTURER. IT WAS REVEALED THAT THE MEASURES WERE IN THE TOLERANCE RANGE AND THE DEVICE WORKED ACCORDING TO ITS SPECIFICATION, THEREFORE THE CLINICAL EXPERT REEVALUATED THE RISK RELATED TO THE ISSUE INVESTIGATED HEREIN AND ASSESSED AS NON-SAFETY NOR RISK-RELATED ISSUE AS THE PLATE CANNOT MOVE DRASTICALLY AS A RESULT AND THE PATIENT IS NOT ENDANGERED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS D11 CONCOMITANT PRODUCTS: 116045BC/116045AC/116059BC PLATES CORRECTED D11 CONCOMITANT PRODUCTS: 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET PREVIOUS E1B EVENT SITE NAME: STMK. KRANKENANSTALT CORRECTED E1B EVENT SITE NAME: GRAZ REGIONAL HSP PREVIOUS H4 DEVICE MANUFACTURE DATE: 12/01/2022 CORRECTED H4 DEVICE MANUFACTURE DATE: 12/12/2022 PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/UNINTENDED MOVEMENT//3026 CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: NO APPARENT ADVERSE EVENT///3189.
ON 23RD FEBRUARY 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED IN COMBINATION WITH 116045BC CARBON FIBRE INSERTABLE PLATE (SHORT),116045AC CARBON FIBRE INSERTABLE PLATE (LONG) OR 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. AS IT WAS STATED, THERE IS A LARGE PLAY AT THE CONNECTION BETWEEN TABLE TOP AND ACCESSORIES (UP TO 5 CM) WHICH MAY POTENTIALLY LEAD TO FAST UNINTENDED MOVEMENT DURING SURGERIES PERFORMED ON CHILDREN. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS DETECTED DURING INITIAL USE. NO SPECIFIC INCIDENT OR INJURY WAS REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IN CASE THE DEVICE IS USED IN CHILDREN'S PROCEDURE AND FAST UNINTENDED MOVEMENT DUE TO PLAY ON HANGING POINTS OCCURS, LEADING TO CHANGE IN THE PATIENT'S POSITION.
ON 23RD FEBRUARY 2023, GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR TABLE TOPS 116010B0 - UNIVERSAL TABLE TOP, SFC, EU USED IN COMBINATION WITH 116045BC CARBON FIBRE INSERTABLE PLATE (SHORT),116045AC CARBON FIBRE INSERTABLE PLATE (LONG) AND 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. AS IT WAS STATED, THERE WAS A LARGE PLAY AT THE CONNECTION BETWEEN TABLE TOP AND ACCESSORIES (UP TO 5 CM) WHICH MAY POTENTIALLY HAVE LED TO FAST UNINTENDED MOVEMENT DURING SURGERIES PERFORMED ON CHILDREN. ACCORDING TO THE PROVIDED INFORMATION, THE ISSUE WAS DETECTED DURING INITIAL USE. IT WAS CLARIFIED WITH THE TECHNICIAN THAT THE PROBLEM EXISTS IN COMBINATION OF 116010B0 - UNIVERSAL TABLE TOP, SFC, EU WITH 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET. NO SPECIFIC INCIDENT OR INJURY WAS REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE BASED ON THE POTENTIAL FOR SERIOUS INJURY IN CASE THE DEVICE IS USED IN CHILDREN'S PROCEDURE AND FAST UNINTENDED MOVEMENT DUE TO PLAY ON HANGING POINTS OCCURS, LEADING TO CHANGE IN THE PATIENT'S POSITION. RECENTLY, NEW INFORMATION WAS PROVIDED BY THE GETINGE TECHNICIAN. THE AFFECTED GETINGE DEVICES HAVE BEEN EVALUATED BY THE COMPANY¿S SERVICE TECHNICIAN AND THE MEASUREMENTS PERFORMED ACCORDING TO THE GUIDELINES OF THE MANUFACTURER. IT WAS REVEALED THAT THE MEASURES WERE IN THE TOLERANCE RANGE AND THE DEVICE WORKED ACCORDING TO ITS SPECIFICATION, THEREFORE THE CLINICAL EXPERT REEVALUATED THE RISK RELATED TO THE ISSUE INVESTIGATED HEREIN AND ASSESSED AS NON-SAFETY NOR RISK-RELATED ISSUE AS THE PLATE CANNOT MOVE DRASTICALLY AS A RESULT AND THE PATIENT IS NOT ENDANGERED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1114798 | UNIVERSAL TABLE TOP, SFC, EU | TABLE, OPERATING-ROOM, AC-POWERED | FQO | MAQUET GMBH | 116010B0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | 116045BC/116045AC/116059BC PLATES| 116059BC - PLATE FOR TRACTION INCL. ACCESSORY SET |