LUCEA 40
Report
- Report Number
- 9710055-2018-00022
- Event Type
- Malfunction
- Date Received
- April 27, 2018
- Date of Event
- March 26, 2018
- Report Date
- June 6, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- KZF
- PMA / PMN Number
- K113679
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- 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)(6). COMMON DEVICE NAME HAS BEEN CORRECTED TO KZF PROCODE. WITH THE COMPLAINT AT HAND, WE RECEIVED AN INFORMATION THAT THE SCREWS WHICH ARE TIGHTENED TO THE LIGHT HEAD COVER HAVE SHEARED AND FELL OFF DUE TO THE LIGHT HEAD COVER BEING DAMAGED. THE ISSUE OCCURRED DURING CLEANING OF THE LIGHT. THERE WAS NO INJURY REPORTED AND NO CONSEQUENCES TO ANY PATIENT. THE PURPOSE OF AFFECTED SCREWS IS TO MAINTAIN THE COVER OF THE LIGHT HEAD TO THE MAIN STRUCTURE. THE DEVICE INVOLVED IN THE EVENT IS LUCEA 40. SERIAL NUMBER OF THE DEVICE IS (B)(4) AND DEFECTIVE PART NUMBER IS ARD568601997. MANUFACTURING DATE IS (B)(6) 2015 AND INSTALLATION DATE OF THE DEVICE IS (B)(6)2017. 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, SCREWS DETACHMENT ARE REPETITIVE SHOCK DURING USE, TOO MUCH FORCE USED TO TIGHTENED SCREWS 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.
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF 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.
MANUFACTURER REFERENCE NUMBER (B)(4).
ON (B)(6) 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- LUCEA 40. AS IT WAS STATED, THE SCREWS WHICH ARE TIGHTENED TO LIGHT HEAD COVER HAVE SHEARED AND FELL OFF. THE ISSUE OCCURRED DURING CLEANING OF THE LIGHT. THERE IS NO INJURY REPORTED AND NO CONSEQUENCES TO PATIENT. (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).
(B)(4). EXEMPTION # E2018005. (B)(4). AS STATED BY THE CUSTOMER THERE WAS NO IMPACT DONE TO THE PART AND HE HANDLES THE CUPOLA BY ITS HANDLE. THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
THE ROOT CAUSE OF THE ISSUE IS ESTABLISHED BY MANUFACTURING SITE HOWEVER, IT NEEDS TO BE CONFIRMED. (B)(4). EXEMPTION # E2018005. (B)(4).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE. (B)(4). EXEMPTION # E2018005. (B)(4).
(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.
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).
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).
(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).
(B)(4). EXEMPTION # E2018005. (B)(4). THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (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 |
|---|---|---|---|---|---|---|---|
| 313478 | LUCEA 40 | DEVICE, MEDICAL EXAMINATION, AC POWERED | KZF | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |