FDA Adverse Event Malfunction Summary report: N

LUCEA

MDR report key: 7984491 · Received October 19, 2018

Report

Report Number: 9710055-2018-00130
Event Type: Malfunction
Date Received: October 19, 2018
Date of Event: September 19, 2018
Report Date: February 27, 2020
Manufacturer: MAQUET SAS
Product Code: FSY
PMA / PMN Number: K113679
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

GETINGE BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- LUCEA 40. AS IT WAS STATED, THE LIGHTS ARE CRACKING ON THE SCREWS AND THERE WAS A POSSIBILITY THAT THE PARTICLES COULD FALL. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. THE INVESTIGATION INTO THE ROOT CAUSE OF THE PROBLEM OCCURRENCE HAS BEEN PERFORMED AND CONCLUDES THAT THE MOST LIKELY ROOT CAUSES OF THE BREAKAGE OF THE COVER AND, CONSEQUENTLY, PARTICLES OF COVER DETACHMENT ARE REPETITIVE SHOCK DURING USE OR INCOMPATIBLE CLEANING PRODUCTS. IN SUMMARY AND BASED ON THE INFORMATION AVAILABLE TO DATE, WHEN THE EVENT OCCURRED, THE DEVICE WAS NOT BEING USED FOR THE PATIENT TREATMENT BUT IT DID PLAY A ROLE IN THE REPORTED EVENT. PERFORMED EVALUATION OF THE INVOLVED DEVICE ALLOWED TO ESTABLISH THAT IT FAILED TO MEET THE MANUFACTURER SPECIFICATION. ALTHOUGH NO INJURY OCCURRED AS A RESULT OF THIS EVENT IT WAS DECIDED TO REPORT BASED ON THE POTENTIAL AND IN ABUNDANCE OF CAUTION. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THE ISSUE IS FOUND TO BE ISOLATED EVENT GETINGE DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.

Additional Manufacturer Narrative · 0

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).

Description of Event or Problem · 0

MANUFACTURER REFERENCE NUMBER 180465.

Description of Event or Problem · 0

ON (B)(4) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- LUCEA. AS IT WAS STATED, THE LIGHTS ARE CRACKING ON THE SCREWS AND THERE IS A POSSIBILITY THAT THE PARTICLES COULD FALL. THERE IS NO INJURY REPORTED HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLE FALLING MIGHT BE A SOURCE OF CONTAMINATION. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURER'S SITE. (B)(4). EXEMPTION # E2018005. (B)(4).

Additional Manufacturer Narrative · 1

THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).