FDA Adverse Event
Other
Summary report: N
MAQUET, CONNECTION FIXTURE
MDR report key: 3234218
·
Received July 15, 2013
Report
- Report Number
- 8010652-2013-00011
- Event Type
- Other
- Date Received
- July 15, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 21, 2013
- Manufacturer
- MAQUET GMBH
- Product Code
- FWZ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS CHECKED BY A MAQUET FIELD REPRESENTATIVE. NO ERROR COULD BE DETECTED WITH THE DEVICE. THE MANUFACTURER BELIEVES THAT ONE OF THE THREE KNOB SCREWS WAS NOT FIXED PROPERLY AND CAME LOOSE, ALLOWING THE HEADREST TO ROCK BACKWARD. THE CUSTOMER WAS RE-TRAINED WITH RESPECT TO PROPER USAGE AND PRE-UTILIZATION INSPECTIONS AS INDICATED IN THE INSTRUCTIONS FOR USE. MAQUET INC SUBMITS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. (B)(4).
Description of Event or Problem · 1
AT THE END OF A SURGICAL PROCEDURE, THE HEAD OF THE PATIENT, WHICH WAS POSITIONED ON THE HEADREST, TILTED OVER DORSALLY. MRI OF CERVICAL SPINE SHOWED NO ISSUE. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327781 | MAQUET, CONNECTION FIXTURE | ACCESSORIES, OPERATING-ROOM, TABLE, FWZ | FWZ | MAQUET GMBH | 1002.65A0 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |