POWERLED
Report
- Report Number
- 9710055-2018-00189
- Event Type
- Malfunction
- Date Received
- November 9, 2018
- Date of Event
- October 15, 2018
- Report Date
- February 21, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE ISSUE IS 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.
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. MAQUET SAS BECAME AWARE OF AN ISSUE WITH A SURGICAL LIGHT POWERLED DEVICE. AS IT WAS STATED, THE PAINT IS BURSTING. THERE WAS NO INDICATION OF AN ADVERSE OUTCOME AND NO FURTHER INFORMATION ABOUT THE CIRCUMSTANCES OF THE EVENT, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLE FALLING INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE SURGICAL LIGHT DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO EVENT. NONE OF THE PROVIDED INFORMATION INDICATE THAT UPON THE EVENT OCCURRENCE THE DEVICE WAS BEING USED FOR PATIENT TREATMENT. DURING THE INVESTIGATION IT WAS FOUND THAT IN THE PAST THE REPORTED SCENARIO HAS TO DATE NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. THE INVOLVED ZONE ON THE DEVICE HAS VISUAL INDICATIONS THAT POINTS TO THE LIKELINESS OF IT HAVING BEEN OVER A PROLONGED TIME PERIOD EXPOSED TO CLEANING AND DISINFECTING AGENTS. THIS WOULD MEAN THAT CLEANING AGENT RESIDUES PASSED THROUGH THE PLASTIC SURFACES, LEADING TO ITS DEGRADATION. THE CONCENTRATION OF CHEMICAL PRODUCTS, THE PRESENCE OF RESIDUAL AGENT ON THE DISINFECTED SURFACES ARE PROBABLY THE MAIN FACTORS LEADING TO THE DETERIORATION OF SURFACES. THE POWERLED USER MANUAL 01581EN ED. 07 PAGE 38 INCLUDES AN INFORMATION TO DAILY CHECK THE DEVICE FOR CHIPPED PAINT. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. 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.
ON (B)(6) 2018 MAQUET SAS BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- POWERLED. AS IT WAS STATED, THE PAINT DISSOLVES FROM THE COVER OF THE LIGHT HEAD. THERE WAS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(6).
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. (B)(4). EXEMPTION # E2018005. (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 |
|---|---|---|---|---|---|---|---|
| 893883 | POWERLED | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | ARD568330933 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |