XS SINGLE FLAT SCREEN HOLDER
Report
- Report Number
- 9710055-2019-00031
- Event Type
- Malfunction
- Date Received
- January 29, 2019
- Date of Event
- January 16, 2019
- Report Date
- August 19, 2019
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ
- Reporter Occupation
- OTHER
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.
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).
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)(6).
THE ISSUE IS STILL BEING INVESTIGATED BY MANUFACTURING SITE.
SECTION D FIELDS HAVE BEEN CORRECTED: BRAND NAME FIELD FROM AXCEL TO XS SINGLE FLAT SCREEN HOLDER CATALOG # FIELD FROM ARD567501286 TO ARD567506996 SERIAL # FIELD FROM(B)(4) TO(B)(4). ON(B)(6)2019 MAQUET SAS BECAME AWARE OF AN ISSUE INITIALLY REPORTED FOR ONE OF SURGICAL LIGHTS- AXCEL. HOWEVER, AFFECTED DEVICE WAS LATER CLARIFIED TO BE XS SINGLE FLAT SCREEN HOLDER . AS IT WAS STATED, CUSTOMER REPORTED HANDLE AND HANDLE ADAPTER WAS MISSING. UPON INSPECTION MISSING PARTS WERE REPLACED. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF TO STERILE FIELD OR DURING SURGERY MIGHT BE A SOURCE OF CONTAMINATION. IT WAS ESTABLISHED THAT WHEN THE EVENT OCCURRED, THE DEVICE DID NOT MEET ITS SPECIFICATION AND IT CONTRIBUTED TO THE ISSUE. NONE OF INFORMATION RECEIVED SO FAR SUGGEST THAT THE ISSUE WAS DISCOVERED DURING PATIENT TREATMENT. THE PROBLEM COVERED BY THE COMPLAINT AT HAND HAS BEEN INVESTIGATED BY THE MANUFACTURING SITE. THE PULL TESTS AND TORSION TESTS HAVE BEEN PERFORMED ON SEVERAL HANDLES TO VERIFY THE RESISTANCE OF THE ADHESIVE BONDING. RESULTS OF A TESTS SHOWED, THAT THE ADHESIVE BONDING IS EFFECTIVE. THE MOST PROBABLE ROOT CAUSE OF THE ISSUE IS DETACHMENT OF THE BONDING PARTS PROBABLY CAUSED BY MECHANICAL SHOCKS, COLLISIONS OR EXCESSIVE EFFORTS. GIVEN THE FINDINGS OF THIS INVESTIGATION, WE SHALL CONTINUE TO MONITOR FOR ANY FURTHER EVENTS OF THIS NATURE.
MANUFACTURERS REFERENCE NUMBER: (B)(4).
ON 16TH JANUARY, 2019 MAQUET (B)(4) BECAME AWARE OF AN ISSUE WITH ONE OF THE SURGICAL LIGHT- AXCEL. AS IT WAS STATED, HANDLE ADAPTER FOR FLAT SCREEN HOLDER DETACHED FROM THE ARM OF THE DEVICE. THERE WAS NO INJURY REPORTED, HOWEVER WE DECIDED TO REPORT THE ISSUE IN ABUNDANCE OF CAUTION AS ANY PARTICLES FALLING OFF TO STERILE FIELD OR DURING SURGERY MIGHT BE A SOURCE OF CONTAMINATION. MANUFACTURERS REFERENCE NUMBER: (B)(4).
MANUFACTURERS REFERENCE NUMBER: (B)(4).
MANUFACTURERS REFERENCE NUMBER: (B)(4).
MANUFACTURERS REFERENCE NUMBER: TW193412.
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'S REFERENCE NUMBER: (B)(4).
MANUFACTURERS REFERENCE NUMBER: (B)(4).
MANUFACTURER'S REFERENCE NUMBER: (B)(4).
MANUFACTURERS REFERENCE NUMBER: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 79109 | XS SINGLE FLAT SCREEN HOLDER | LIGHT, SURGICAL, CEILING MOUNTED | FSY | MAQUET SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |