HANAULUX 3000
Report
- Report Number
- 9710055-2019-00022
- Event Type
- Malfunction
- Date Received
- January 25, 2019
- Date of Event
- January 11, 2019
- Report Date
- October 28, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
GETINGE BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- HANAULUX 3000. AS IT WAS STATED, THE RUBBER BUMPER HAS FALLEN DURING CLEANING OF THE DEVICE. THERE WAS NO INJURY REPORTED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING OFF 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. THERE IS NO INFORMATION IF IN THE TIME WHEN THE EVENT OCCURRED THE DEVICE WAS OR WAS NOT BEING USED FOR PATIENT TREATMENT. AS PER PERFORMED TESTS THE ROOT CAUSE OF FALLING BUMPER IS LIKELY CAUSED BY SEVERAL VIOLENT COLLISIONS WITH THE CUPOLAS, THIS CAN HAPPEN WHEN THE USER IS NOT BEING CAREFUL WITH MOVING THE DEVICE ARMS AND LIGHTS. HOWEVER, THE BUMPER OF THE SURGICAL LIGHT AFFECTED WAS MANUFACTURED BEFORE IMPLEMENTATION OF HARDNESS CHANGE TO PREVENT THE BUMPER FROM FALLING. WE BELIEVE THAT ALL REMAINING DEVICES ARE PERFORMING CORRECTLY IN THE MARKET. GETINGE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE AND DO NOT PROPOSE ANY FURTHER ACTIONS.
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 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).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER 2019-62165.
ON (B)(4) 2019 MAQUET SAS BECAME AWARE OF AN ISSUE WITH ONE OF SURGICAL LIGHTS- HANAULUX 3000. AS IT WAS STATED, THE RUBBER CAP HAS FALLEN DURING CLEANING OF THE DEVICE. THERE WAS NO INJURY REPORTED. WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PART FALLING OFF INTO STERILE FIELD OR DURING PROCEDURE MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURER REFERENCE NUMBER (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.
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.
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
(B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
MANUFACTURER REFERENCE NUMBER (B)(4).
MANUFACTURER'S REFERENCE NUMBER (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 69839 | HANAULUX 3000 | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS | ARD567904999 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |