POWERLED
Report
- Report Number
- 9710055-2018-00056
- Event Type
- Malfunction
- Date Received
- July 17, 2018
- Report Date
- November 8, 2018
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
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 INVESTIGATED BY MANUFACTURING SITE.
MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED DEVICE AS STATED IN THE COMPLAINT, THE HANDLE AROUND THE LIGHT WAS DISCOVERED BROKEN BY DOCTOR, WHO TRIED TO ADJUST THE LIGHT AT THE BEGINNING OF THE SURGICAL PROCEDURE. FORTUNATELY, THERE WAS NO ADVERSE OUTCOME REPORTED. THE FACILITY MAINTENANCE STAFF SUPERGLUED AND TAPED THE HANDLE BACK ON. THE ISSUE WAS RAISE TO THE COMPANY¿S REPRESENTATIVE. THE TECHNICIAN VISITED THE FACILITY AND FOUND TWO OF THE TREE BRACKETS HOLDING THE HANDLE FAULTY. HE WAS ABLE TO REPAIR THE DEVICE BY REPLACING THE HANDLE. AFTER THE REPLACEMENT, THE DEVICE WAS RETURNED TO USE. THE DEVICE HAS BEEN RECOGNIZED AS POWERLED WITH THE SERIAL NUMBER: (B)(6). DEFECTIVE PART NUMBER IS ARD568303999. DEVICE WAS MANUFACTURED IN 13TH SEPTEMBER, 2007 AND IS NOT UNDER GETINGE SERVICE AGREEMENT. DURING THE INVESTIGATION IT WAS FOUND THAT THERE IS NO APPARENT TREND WITH THE ISSUE AT HAND AND THAT THE REPORTED SCENARIO HAS NEVER LED TO SERIOUS INJURY OR WORSE. LOOKING AT THE AGE OF PRODUCT (11 YEARS) WE CAN CONCLUDE THAT THE ISSUE IS THE RESULT OF WEAR AND TEAR AND THERE COULD BE SEVERAL SHOCKS OF THE HANDLE. IN SUMMARY, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT, THUS THE MAQUET DEVICE PLAYED A ROLE ON THE EVENT. GIVEN THE CIRCUMSTANCES AND THE FACT THAT MAQUET HAD INSTALLED APPROXIMATELY 33670 POWER LED DEVICES TO DATE AND THIS COMPLAINT IS THE 3RD ONE OF THIS NATURE, WE BELIEVE THE RELATED DEVICES ARE PERFORMING CORRECTLY IN THE MARKET AND DO NOT PROPOSE ANY FURTHER ACTION AS THIS TIME. WE ALSO BELIEVE THAT IF THE MANUFACTURER RECOMMENDATION WOULD HAVE BEEN FOLLOWED THE INCIDENT WOULD HAVE BEEN AVOIDED. 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. CONTACT PERSON: (B)(4).
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).
ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- POWERLED. AS STATED IN THE COMPLAINT, THE HANDLE AROUND THE LIGHT HAS BROKEN AT THE BEGINNING OF THE CASE. THERE IS NO INJURY REPORTED. MFG REFERENCE NUMBER IS 171399-2018-000378.
MFG REFERENCE NUMBER IS (B)(4).
MFG REFERENCE NUMBER IS (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
MFG REFERENCE NUMBER IS (B)(4).
MFG REFERENCE NUMBER IS (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535307 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |