LUCEA 40
Report
- Report Number
- 9710055-2018-00017
- Event Type
- Injury
- Date Received
- April 17, 2018
- Date of Event
- December 30, 2017
- Report Date
- June 6, 2019
- Manufacturer
- FREDERIC LELEU - MAQUET SAS
- Product Code
- KZF
- PMA / PMN Number
- K113679
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- 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 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. (B)(6). WITH THE COMPLAINT AT HAND, WE RECEIVED AN INFORMATION ONE OF OUR SURGICAL LIGHTS CREATED A DISTURBANCE IN THE OPERATION OF A CARDOTOCOGRAPHY (CTG) USED IN A DELIVERY ROOM AT THE HOSPITAL. THE PROBLEM WAS DESCRIBED AS CTG INDICATING VALUES, REGISTERED FROM THE POWER SUPPLY INSTEAD OF THE BABY¿S HEARTBEAT. THIS WAS NOTICED ONCE THE CTG TRANSDUCERS WERE DISCONNECTED AND PLACED NEXT TO THE GETINGE DEVICE. IT HAS ALSO BEEN STATED THAT HEARTBEAT VALUES WERE SHOWN AS INCORRECTLY INCREASED DUE TO THE POWER SUPPLY DISTURBANCE. THE ISSUE ALLEGEDLY CAUSED AN NAVEL SWELLING WITH A BABY DURING DELIVERY, HOWEVER THE BABY RECOVERED QUICKLY AFTER. THE DEVICE INVOLVED IN THE EVENT IS LUCEA 40 EXAMINATION LIGHT. SERIAL NUMBER OF THE DEVICE IS AR010200 AND DEFECTIVE PART NUMBER IS ARD568601998. MANUFACTURING DATE IS 7TH MARCH, 2011 AND INSTALLATION DATE OF THE DEVICE IS UNKNOWN. THE INVESTIGATION INTO THE ROOT CAUSE OF THE PROBLEM OCCURRENCE HAS BEEN PERFORMED. A REQUEST FOR THE DEFECTIVE PART RETURN WAS ISSUED SEVERAL TIMES BUT THE CUSTOMER HAVE NOT RESPONDED TO ANY OF GETINGE REQUESTS. UNFORTUNATELY, DUE TO THE FACT THAT THIS INCIDENT IS CONSIDERED TO BE SINGLE AND ISOLATED CASE AND IT WAS NOT POSSIBLE TO RECEIVE THE DEFECTIVE PART, WE WERE NOT ABLE TO CONFIRM THE CUSTOMER ALLEGATION NOR ESTABLISH A ROOT CAUSE OF THE DISTURBANCE OCCURRENCE. THE LUCEA 40 LIGHT HAS THE CERTIFICATE OF CONFORMITY CEM R130-09-105265-2 WITH THE DIRECTIVE 2004/108/EC REGARDING ELECTROMAGNETIC COMPATIBILITY. THE EMC DECLARATION IS ALSO INCLUDED IN THE LUCEA 40 USER MANUAL 01711EN ED. 04 PAGES 23-24. IN SUMMARY AND BASED ON THE INFORMATION AVAILABLE TO DATE, WHEN THE EVENT OCCURRED, THE DEVICE WAS BEING USED FOR THE PATIENT TREATMENT. PROVIDED CUSTOMER ALLEGATION COULD INDICATE THAT IT FAILED TO MEET THE MANUFACTURER SPECIFICATION. GIVEN THE CIRCUMSTANCES AND THE FACT THAT THE ISSUE IS FOUND TO BE SINGLE AND ISOLATED EVENT GETINGE DOES NOT PROPOSE ANY FURTHER ACTION AT THIS TIME.
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.
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
ON 20TH MARCH, 2018 MAQUET (B)(4) BECAME AWARE OF AN INCIDENT WITH ONE OF SURGICAL LIGHTS- LUCEA 40. AS IT WAS STATED BY CUSTOMER, POWER SUPPLY RELATED TO THIS SURGICAL LIGHT CREATED NOISE ON CTG IN DELIVERY ROOM AT HOSPITAL CAUSING THE CTG TO REGISTER NOISE FROM THE POWER SUPPLY INSTEAD OF THE BABY'S HEARTSOUND. THE ISSUE CAUSED AN OUTCOME TO A BABY DURING DELIVERY, HOWEVER THE BABY RECOVERED QUICKLY AFTER THE ISSUE. THE ISSUE CAUSED NAVEL NEPHROGEN. (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. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
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.
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).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
MANUFACTURER REFERENCE PROBLEM (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281398 | LUCEA 40 | DEVICE, MEDICAL EXAMINATION, AC POWERED | KZF | FREDERIC LELEU - MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |