BLUELINE
Report
- Report Number
- 9710055-2023-00041
- Event Type
- Malfunction
- Date Received
- January 18, 2023
- Report Date
- January 18, 2023
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ BLUELINE. AS IT WAS STATED, THERE WERE MISSING COVER. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN AN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF INTO A STERILE FIELD OR DURING A PROCEDURE MAY CAUSE CONTAMINATION. NEW INFORMATION WAS PROVIDED BY GETINGE QRC MANAGER AFTER THE COMMUNICATION WITH CUSTOMER. IT WAS CONFIRMED THAT THERE WERE NO MISSING COVERS. CUSTOMER WOULD LIKE TO ORDER THE COVERS ON STOCK. THEREFORE, THE INITIALLY CONSIDERED POTENTIAL RISK OF CONTAMINATION CAN BE EXCLUDED. THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. IT WAS ESTABLISHED THAT THE DEVICE DID NOT FAIL TO MEET ITS SPECIFICATIONS AND IT ALSO DID NOT CONTRIBUTE TO THE EVENT. AS THE INITIAL ALLEGATION COULD NOT BE CONFIRMED, THERE WAS NO RISK OF POTENTIAL CONSEQUENCES IF THE DEVICE WOULD BE USED FOR PATIENT TREATMENT. BASED ON THE INFORMATION PROVIDED BY GETINGE QRC MANAGER, THERE WERE NO POTENTIAL OF COVERS MISSING, IT CAN BE CONCLUDED THERE WAS NO TECHNICAL ISSUE. THEREFORE, THE ROOT CAUSE CANNOT BE CONFIRMED. AFTER REVIEWING THE INFORMATION PROVIDED FOR THE CUSTOMER PRODUCT COMPLAINTS INVESTIGATED HERE COMPLAINT HANDLER DID NOT IDENTIFY ANY APPARENT REASON FOR SUGGESTING TO OPEN CAPA OR EVALUATION FOR THE NEED OF AN ACTION IN THE MARKET. IT IS NOT LIKELY THAT IT COULD LEAD TO THE SERIOUS INJURY OR DEATH WHEN THE MALFUNCTION REOCCURS. THAT IS WHY IT IS NOT CONSIDERED TO BE SAFETY RELATED AND REPORTABLE. THE CORRECTION OF B5 DESCRIBE EVENT OR PROBLEM, D1 BRAND NAME, H3A DEVICE EVALUATED BY MANUFACTURER, H3B DEVICE NOT EVAL PROVIDE CODE AND H3C IF OTHER PROVIDE CODE - EXPLAIN FIELDS DEEMS REQUIRED. THIS IS BASED ON THE INTERNAL EVALUATION AND ADDITIONAL INFORMATION THAT HAS BEEN RECEIVED. PREVIOUS B5 DESCRIBE EVENT OR PROBLEM: ON 24TH FEBRUARY 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ BLUE 30. AS IT WAS STATED, SPRING'S ARM COVERS WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. CORRECTED B5 DESCRIBE EVENT OR PROBLEM: ON 24TH FEBRUARY 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ BLUELINE ¿ BLUE 30. ON 12TH JANUARY 2023, SERVICE TECHNICIAN ARRIVED ON SITE AND CHECKED THE DEVICES, ADJUSTED ALL TUBE BRAKES. DURING COMMUNICATION WITH THE TECHNICIAN, IT BECAME KNOWN THAT SPRING'S ARM COVERS WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. HOWEVER, AFTER THE DISCUSSION WITH QRC MANAGER FROM AUSTRALIA, IT TURNED OUT THAT THE TECHNICIAN HAD GIVEN THE WRONG INFORMATION AND ALL THE COVERS WERE IN PLACE AND THE COVERS WERE ORDERED ONLY FOR STOCK. BASED ON THIS INFORMATION FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY NOR RISK RELATED, AS THERE WAS NO INDICATION OF MISSING PARTS, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE. PREVIOUS D1 BRAND NAME: BLUE 30. CORRECTED D1 BRAND NAME: BLUELINE. 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. PREVIOUS H6 MEDICAL DEVICE ¿ PROBLEM CODE: MECHANICAL PROBLEM/DETACHMENT OF DEVICE OR DEVICE COMPONENT//2907. CORRECTED H6 MEDICAL DEVICE ¿ PROBLEM CODE: NO APPARENT ADVERSE EVENT///3189.
ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE INVESTIGATION.
ON 24TH FEBRUARY 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ BLUELINE ¿ BLUE 30. ON 12TH JANUARY 2023, SERVICE TECHNICIAN ARRIVED ON SITE AND CHECKED THE DEVICES, ADJUSTED ALL TUBE BRAKES. DURING COMMUNICATION WITH THE TECHNICIAN, IT BECAME KNOWN THAT SPRING'S ARM COVERS WERE MISSING. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION. HOWEVER, AFTER THE DISCUSSION WITH QRC MANAGER FROM AUSTRALIA, IT TURNED OUT THAT THE TECHNICIAN HAD GIVEN THE WRONG INFORMATION AND ALL THE COVERS WERE IN PLACE AND THE COVERS WERE ORDERED ONLY FOR STOCK. BASED ON THIS INFORMATION FROM GETINGE EMPLOYEE IT WAS POSSIBLE TO DETERMINE THAT THE ISSUE INVESTIGATED HEREIN IS NOT SAFETY NOR RISK RELATED, AS THERE WAS NO INDICATION OF MISSING PARTS, WHICH WAS INITIALLY CONSIDERED. THEREFORE, THE SCENARIO DESCRIBED IN THE RECORD IS CONSIDERED AS NON-REPORTABLE.
ON 24TH FEBRUARY 2021 GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF OUR SURGICAL LIGHTS ¿ BLUE 30. AS IT WAS STATED, SPRING'S ARM COVERS WERE MISSING. THERE WAS NO INJURY REPORTED, HOWEVER, WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MAY CAUSE CONTAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925123 | BLUELINE | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |