ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL
Report
- Report Number
- 8010652-2024-00006
- Event Type
- Malfunction
- Date Received
- January 16, 2024
- Date of Event
- January 5, 2024
- Report Date
- January 16, 2024
- Manufacturer
- MAQUET GMBH
- Product Code
- FQO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113312B3 - ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL. AS IT WAS STATED, THE TABLE WAS TILTING TO THE RIGHT WHEN AN ANESTHETIZED PATIENT WAS LYING ON IT AND USERS HAD TO KEEP RE-SETTING THE TABLE. THE ISSUE LED TO A MINIMAL DELAY IN PROCEDURE. 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 OF THE OPERATING TABLE WITH ANESTHETIZED PATIENT, 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 WERE ALSO DIRECTLY INVOLVED WITH THE REPORTED INCIDENT. AS THE MALFUNCTION WAS CLAIMED, IT WAS CONSIDERED THAT THE GETINGE DEVICE FAILED TO MEET ITS SPECIFICATION. A REVIEW OF THE RECEIVED CUSTOMER PRODUCT COMPLAINTS REVEALED THAT IN THE PAST THERE WAS NO SERIOUS INJURY TO THE PATIENT OR USER WHEN THIS PARTICULAR ISSUE OCCURRED. THE SUBJECT MATTER EXPERT FROM MANUFACTURING SITE SUSPECTED THE CUSTOMER DID NOT FOLLOW INSTRUCTION FOR USE STATING THAT THE FUNCTIONS MUST BE MOVED IN THE MORNING BEFORE THE SURGICAL PROGRAM. THE HYDRAULIC SYSTEM PRESSURE IN THE TILT FUNCTION (TILT RIGHT) DECREASES OVER TIME AND ADJUSTMENTS ARE REQUIRED. IN THE IFU ( GA 113312 REV 2, PAGE 32), AFTER STANDSTILLS, THE USER IS ADVISED TO ACTUATE THE OPERATING TABLE FUNCTIONS TO CHECK PROPER FUNCTIONING BEFORE POSITIONING THE PATIENT. THE CUSTOMER WAS CONTACTED TO OBTAIN FOLLOW UP INFORMATION ABOUT THE REPORTED INCIDENT. HOWEVER, THE CUSTOMER DID NOT REPLY. 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 OF THE OPERATING TABLE WITH ANESTHETIZED PATIENT, IS RELATED TO THE USER NOT ADHERING TO INSTRUCTION FOR USE. 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. 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, H3C IF OTHER PROVIDE CODE - EXPLAIN, H4 DEVICE MANUFACTURE DATE FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 5TH JANUARY 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113312B3 - ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL. AS IT WAS STATED, THE TABLE WAS TILTING TO THE RIGHT WHEN AN ANESTHETIZED PATIENT WAS LYING ON IT AND USERS HAD TO KEEP RE-SETTING THE TABLE. THE ISSUE LED TO A MINIMAL DELAY IN PROCEDURE. 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 OF THE OPERATING TABLE 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 - 113312B3 - ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL. AS IT WAS STATED, THE TABLE WAS TILTING TO THE RIGHT WHEN AN ANESTHETIZED PATIENT WAS LYING ON IT AND USERS HAD TO KEEP RE-SETTING THE TABLE. THE ISSUE LED TO A MINIMAL DELAY IN PROCEDURE. 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 OF THE OPERATING TABLE WITH ANESTHETIZED PATIENT, WAS TO REOCCUR. PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: CUSTOMER INSPECTION PREVIOUS H4 DEVICE MANUFACTURE DATE: 2006-01-15 CORRECTED H4 DEVICE MANUFACTURE DATE: 2006-01-10.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. E1: EVENT SITE TELEPHONE: (B)(6). H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113312B3 - ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL. AS IT WAS STATED, THE TABLE WAS TILTING TO THE RIGHT WHEN AN ANESTHETIZED PATIENT WAS LYING ON IT AND USERS HAD TO KEEP RE-SETTING THE TABLE. THE ISSUE LED TO A MINIMAL DELAY IN PROCEDURE. 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 OF THE OPERATING TABLE WITH ANESTHETIZED PATIENT, WAS TO REOCCUR.
ON (B)(6) 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR MOBILE TABLES - 113312B3 - ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL. AS IT WAS STATED, THE TABLE WAS TILTING TO THE RIGHT WHEN AN ANESTHETIZED PATIENT WAS LYING ON IT AND USERS HAD TO KEEP RE-SETTING THE TABLE. THE ISSUE LED TO A MINIMAL DELAY IN PROCEDURE. 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 OF THE OPERATING TABLE AND DELAY IN SURGERY RESULTING IN PROLONGED ANESTHESIA TIME, WAS TO REOCCUR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1677229 | ALPHAMAXX MOTOR DRIVE UNIT, EU SIDE RAIL | TABLE, OPERATING-ROOM, AC-POWERED | FQO | MAQUET GMBH | 113312B3 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |