XS SINGLE FLAT SCREEN HOLDER
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Report
- Report Number
- 9710055-2023-00532
- Event Type
- Malfunction
- Date Received
- July 21, 2023
- Report Date
- July 21, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FXR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PREVIOUS B5 DESCRIBE EVENT AND PROBLEM: ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE HANDLE WAS MISSING FROM MONITOR HOLDER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. CORRECTED B5 DESCRIBE EVENT AND PROBLEM: ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THE HANDLE WAS MISSING FROM MONITOR HOLDER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. PREVIOUS D1 BRAND NAME: POWERLED 700 CORRECTED D1 BRAND NAME: XS SINGLE FLAT SCREEN HOLDER PREVIOUS D2 PRODUCT CODE. FSY CORRECTED D2 PRODUCT CODE. FXR PREVIOUS D4 VERSION OR MODEL # ARD568371938 CORRECTED D4 VERSION OR MODEL # ARD567506996 PREVIOUS D4 CATALOG # ARD568371938 CORRECTED D4 CATALOG # ARD567506996 PREVIOUS D4 SERIAL # 500195 CORRECTED D4 SERIAL # (B)(6). ACCORDING TO THE REPORTING TIMEFRAME WE WOULD LIKE TO PROVIDE THE INFORMATION ABOUT CURRENT STATUS OF THE ISSUE. PLEASE BE ADVISED THAT IT IS BEING INVESTIGATED. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION. H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.
THE CORRECTION OF H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE, H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION. PREVIOUS H3A DEVICE EVALUATED BY MANUFACTURER: NO CORRECTED H3A DEVICE EVALUATED BY MANUFACTURER: YES PREVIOUS H3B DEVICE NOT EVAL PROVIDE CODE: OTHER CORRECTED H3B DEVICE NOT EVAL PROVIDE CODE: N/A PREVIOUS H3C IF OTHER PROVIDE CODE - EXPLAIN: DEVICE NOT RETURNED TO MANUFACTURER CORRECTED H3C IF OTHER PROVIDE CODE - EXPLAIN: N/A THE UNIQUE IDENTIFIER (UDI) # INFORMATION IS NOT AVAILABLE AS THIS MEDICAL DEVICE/MODEL WAS MARKETED AND/OR DISCONTINUED IN US BEFORE THE UDI REQUIREMENT BECAME MANDATORY. GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THE HANDLE WAS MISSING FROM MONITOR HOLDER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY. BASED ON AN INFORMATION GATHERED, THE DEFECTIVE HANDLE HOLDER - ARD567701135 WAS REPLACED. BASED ON THE INFORMATION COLLECTED, IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IN THIS WAY THE DEVICE CONTRIBUTED TO EVENT. THE DEVICE WAS NOT BEING USED FOR PATIENT TREATMENT UPON THE EVENT OCCURRENCE. ROOT CAUSE WAS REPORTED BY SUBJECT MATTER EXPERT AT THE MANUFACTURER. AS THEY STATED: IT WAS REPORTED THAT THE HANDLE WAS MISSING ON THE MONITOR HOLDER. THE ISSUE WAS DISCOVERED DURING ROUTINE CHECKING'S BY THEIR NURSE STAFF. ACCORDING TO THE INFORMATION PROVIDED NO HANDLE WAS LOCATED, OR FOUND. NO BREAKAGES OR MALFUNCTIONS HAVE BEEN REPORTED. IT IS STATED THAT AN ARD567701135 HANDLE HOLDER HAS BEEN FITTED. THE REASON FOR THIS IS NOT STATED. NO PHOTOGRAPHIC EVIDENCE OR ADDITIONAL INFORMATION WERE PROVIDED IN ORDER TO BE ABLE TO OBSERVE A POSSIBLE ANOMALY OF THE DEVICE. THE INFORMATION COLLECTED IS NOT SUFFICIENT TO DETERMINE THE CAUSE OF A POTENTIAL FAILURE. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL EQUIPMENT - XS SINGLE FLAT SCREEN HOLDER. IT WAS STATED THE HANDLE WAS MISSING FROM MONITOR HOLDER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.
ON 12TH JULY, 2023 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS - POWERLED 700. IT WAS STATED THE HANDLE WAS MISSING FROM MONITOR HOLDER. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE SERIOUS INJURY.
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2254891 | XS SINGLE FLAT SCREEN HOLDER | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567506996 | ||
| 2263610 | XS SINGLE FLAT SCREEN HOLDER | HOLDER, CAMERA, SURGICAL | FXR | MAQUET SAS | ARD567506996 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |