PRISMALIX
Report
- Report Number
- 9710055-2018-00129
- Event Type
- Malfunction
- Date Received
- October 17, 2018
- Report Date
- February 4, 2020
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K982063
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC
- Reporter Occupation
- PHARMACIST
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. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTUING SITE.
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
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. CONTACT PERSON: (B)(4).
GETINGE RECEIVED A CUSTOMER PRODUCT COMPLAINT WITH AN ALLEGATION ABOUT CORROSION APPEARING ON THE PRISMALIX DEVICE. THERE WERE NO ADVERSE CONSEQUENCES REPORTED HOWEVER WE DECIDED TO REPORT THE COMPLAINT TO COMPETENT AUTHORITIES BASED ON THE POTENTIAL FOR HARM, AS ANY PARTICLE FALLING INTO THE STERILE FIELD 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 INDICATES 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 NEVER LEAD TO SERIOUS INJURY OR WORSE, TO DEATH. CORRODED SURFACE IS INDICATED BY OUR PRODUCT EXPERTS TO LIKELY BE CAUSED BY AN INFLUENCE OF CHEMICAL DETERGENTS USED FOR CLEANING. THE PERFORMED INVESTIGATION LED TO THE CONCLUSION THAT THAT MOST PROBABLY ROOT CAUSE IS CONNECTED WITH CHEMICAL PRODUCTS AND THE STAGNATION OF SUBSTANCE RESIDUES IN THE SURFACES. 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 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.
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER #181508.
MANUFACTURER REFERENCE NUMBER #181508.
ON (B)(4) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- PRISMALIX. AS IT WAS STATED, THE CORROSION OCCURRED ON THE DEVICE. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY RUST PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER #(B)(4).
MANUFACTURER'S REFERENCE NUMBER 181508.
MANUFACTURER REFERENCE NUMBER #(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.
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. (B)(4). EXEMPTION # E2018005. (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
(B)(4).
MANUFACTURER REFERENCE NUMBER: (B)(4).
MANUFACTURER REFERENCE NUMBER # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816737 | PRISMALIX | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |