AXIS SUSPENSION TUBE LG 650
Report
- Report Number
- 9710055-2024-00196
- Event Type
- Malfunction
- Date Received
- March 7, 2024
- Date of Event
- March 4, 2024
- Report Date
- March 7, 2024
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
E1B EVENT SITE NAME: (B)(6) HOSPITAL. E1I EVENT SITE TELEPHONE: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
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
THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE SINCE THE DEVICE WAS MANUFACTURED BEFORE SEPTEMBER 2016. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL EQUIPMENT - AXIS SUSPENSION TUBE LG 650. IT WAS STATED THE ELBOW COVER WAS BROKEN AND STAFF MEMBER CUT THE FINGER. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, FOR A FINGER CUT, WASH AND BAND AID WERE REQUIRED, AND THE STAFF MEMBER CONDITION IS GOOD. FOLLOWING THE VISIT AT THE CUSTOMER SITE AND DEVICE EVALUATION FURTHER INFORMATION WAS PROVIDED BY GETINGE TECHNICIAN, THE SPRING ARM WAS BEING KEPT DOWN BY THE USE OF A WEIGHTED OBJECT TAPED TO IT. TWO OF THE STAINLESS STEEL DUST COVERS WERE DAMAGED AND HAD COME OUT OF THEIR GUIDING TRACKS. THE MONITOR BOOM HAS BEEN BROKEN FOR A LONG TIME AND IT NEEDS COUNTERBALANCE ADJUSTMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS FINGER CUT MAY LEAD TO SERIOUS INJURY. BASED ON AN INFORMATION GATHERED, THE DEFECTIVE PART (S/A REP ONDASPACE RAL9016 SIDE COVERS - ARD315018555) WAS REPLACED. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE MAQUET EQUIPMENT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. PROVIDED INFORMATION DOES NOT INDICATE IF UPON THE EVENT OCCURRENCE, THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. AS STATED BY THE SUBJECT MATTER EXPERT AT THE MANUFACTURING SITE, THE INCIDENT IS DUE TO INAPPROPRIATE USE. THE OPERATING MANUAL INCLUDES THE INSTRUCTIONS TO PRE-POSITION THE ARMS PRIOR TO USE, IN ORDER TO PREVENT DAMAGES. ADDITIONALLY, THE USERS ARE REQUESTED TO PAY ATTENTION TO CRACKS IN PLASTIC PARTS. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
ON 4TH MARCH, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR PENDANTS - SVH RP. IT WAS STATED THE ELBOW COVER WAS BROKEN AND STAFF MEMBER CUT THE FINGER. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN THE STAFF MEMBER IS OK. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS CUT OF THE FINGER MAY LEAD TO SERIOUS INJURY.
ON 4TH MARCH, 2024 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL EQUIPMENT - AXIS SUSPENSION TUBE LG 650. IT WAS STATED THE ELBOW COVER WAS BROKEN AND STAFF MEMBER CUT THE FINGER. ACCORDING TO THE INFORMATION PROVIDED BY GETINGE TECHNICIAN, FOR A FINGER CUT, WASH AND BAND AID WERE REQUIRED, AND THE STAFF MEMBER CONDITION IS GOOD. FOLLOWING THE VISIT AT THE CUSTOMER SITE AND DEVICE EVALUATION FURTHER INFORMATION WAS PROVIDED BY GETINGE TECHNICIAN, THE SPRING ARM WAS BEING KEPT DOWN BY THE USE OF A WEIGHTED OBJECT TAPED TO IT. TWO OF THE STAINLESS STEEL DUST COVERS WERE DAMAGED AND HAD COME OUT OF THEIR GUIDING TRACKS. THE MONITOR BOOM HAS BEEN BROKEN FOR A LONG TIME AND IT NEEDS COUNTERBALANCE ADJUSTMENT. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS FINGER CUT MAY LEAD TO SERIOUS INJURY.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1976394 | AXIS SUSPENSION TUBE LG 650 | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD515073999 | ||
| 526223 | AXIS SUSPENSION TUBE LG 650 | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD515073999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |