SAT XS 13
Report
- Report Number
- 9710055-2019-00021
- Event Type
- Malfunction
- Date Received
- January 25, 2019
- Date of Event
- January 3, 2019
- Report Date
- February 12, 2020
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA
- Reporter Occupation
- OTHER
Narratives
GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF ANCHORING, CEILING SYSTEM ¿ SATELITE. AS IT WAS STATED, THE END CAP DETACHED FROM THE DEVICE. THERE WAS NO INFORMATION ABOUT PATIENT INVOLVEMENT HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTS FALLING COULD LED TO SERIOUS INJURY. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. THE PROVIDED INFORMATION DID NOT INDICATE THAT THE DEVICE WAS BEING USED FOR PATIENT TREATMENT WHEN THE EVENT TOOK PLACE. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS NEVER LED TO SERIOUS INJURY, NOR DEATH. OUR INVESTIGATION FINDS THAT A DETACHED END CAP WOULD BE MOST LIKELY CAUSED BY LACK OF MAINTENANCE OR IMPROPER HANDLING OF THE DEVICE. WE BELIEVE THAT REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATIONS 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.
THE ISSUE IS STILL BEING 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. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
MANUFACTURER REFERENCE NUMBER 192055.
ON (B)(6) 2019 (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF PARTS OF SURGICAL LIGHT- SAT XS 13. AS IT WAS STATED, THE END CAP CAME OFF. THERE WAS NO INJURY REPORTED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER: (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69696 | SAT XS 13 | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |