XTEN
Report
- Report Number
- 9710055-2018-00012
- Event Type
- Malfunction
- Date Received
- March 22, 2018
- Date of Event
- February 20, 2018
- Report Date
- June 21, 2018
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K040735
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE ISSUE IS INVESTIGATED BY MANUFACTURING SITE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. IMPORTER_ GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). THE ISSUE IS STILL UNDER MAUFACTURING SITE INVESTIGATION.
MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT XTEN DEVICE. AS STATED BY THE CUSTOMER, THE PAINT IS PEELING OFF FROM SPRING ARM AND SUSPENSION ARM IN ONE OF OPERATING THEATERS. THE PAINT COULD FELL DOWN. THERE WAS NO PATIENT INVOLVEMENT. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. AT THE TIME WHEN THE EVENT OCCURRED, THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. AS THE PREVENTIVE MAINTENANCE OF THE DEVICE IS BEING MADE ONLY BY THE HOSPITAL¿S PERSONNEL, THE ASSUMED ROOT CAUSE IN THE MANUFACTURER¿S INVESTIGATION IS LIKELY CAUSED BY A SHOCK DURING A COLLISION. THE PRODUCT XTEN USER MANUAL 0130103 ED. 3A PAGE 26 THERE IS AN INFORMATION TO DAILY CHECK THE DEVICE FOR CHIPPED PAINT. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT COULD HAVE BEEN AVOIDED. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THERE IS NO APPARENT TREND IN COMPLAINTS OF THIS NATURE WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTION AT THIS TIME. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074 . EXEMPTION # E2018005. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(6).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET SAS, PARC DE LIMÈRE, AVENUE DE LA POMME DE PI ORLÉANS CEDEX 2, FRANCE 45074. EXEMPTION # E2018005. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- XTEN. AS STATED BY THE CUSTOMER, THE PAINT IS PEELING OFF FROM SPRING ARM AND SUSPENSION ARM IN ONE OF OPERATING THEATERS AND IT ALMOST FELL DOWN DURING A PROCEDURE. (B)(4).
MANUFACTURING REFERENCE NUMBER: (B)(4).
MANUFACTURING REFERENCE NUMBER: (B)(4).
MANUFACTURING REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203837 | XTEN | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |