POWERLED
Report
- Report Number
- 9710055-2017-00069
- Event Type
- Malfunction
- Date Received
- October 31, 2017
- Date of Event
- September 29, 2017
- Report Date
- July 19, 2018
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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. 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 SURGICAL LIGHT HAS BEEN REPAIRED AND ALL PARTS HAVE BEEN SECURED WITH LOCTITE GLUE.
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).
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). MAQUET SAS BECAME AWARE OF AN INCIDENT WITH A SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED, THE SPRING ARM FLANGE COVER SHAFT SCREW BECAME LOOSE AND MADE A CONTACT WITH PATIENT. THERE WAS NO PATIENT INJURY HOWEVER WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE EVENT. AT THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. THE ROOT CAUSE IS AN INCORRECT TIGHTENING OF COVERS SIDE SCREWS AT THE INSTALLATION OR DURING MAINTENANCE. THE FALL OF THE PLASTIC CAP IS THE DIRECT RESULT OF A LOOSENED SCREW AND A LACK OF VERIFICATION DURING YEARLY MAINTENANCE. 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 THIS IS THE FIRST COMPLAINT 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.
(B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
(B)(4). EXEMPTION # E2018005. (B)(4). THE INVESTIGATION HAS BEEN FINALIZED BY MANUFACTURING SITE, HOWEVER THE ROOT CAUSE NEEDS TO BE CONFIRMED.
(B)(4). THE ISSUE WILL BE INVESTIGATED BY MANUFACTURING SITE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION IS RECEIVED.
MANUFACTURER REFERENCE NUMBER (B)(4).
ON (B)(6) 2017 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, SPRING ARM FLANGE COVER SHAFT SCREW BECAME LOOSE AND MADE A CONTACT WITH PATIENT. THERE WAS NO PATIENT INJURY HOWEVER WE DECIDED TO REPORT THIS ISSUE IN ABUNDANCE OF CAUTION. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 771539 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |