FDA Adverse Event
Malfunction
Summary report: N
MAQUET EXTENSION DEVICE TO YUNO OR TABLE
MDR report key: 3192581
·
Received June 20, 2013
Report
- Report Number
- 8010652-2013-00009
- Event Type
- Malfunction
- Date Received
- June 20, 2013
- Manufacturer
- MAQUET GMBH
- Product Code
- FWZ
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER WAS ABLE TO DEMONSTRATE TO A MAQUET REPRESENTATIVE THE FAILURE IN LOCKING MECHANISM. THE MANUFACTURER HAS ASKED THE CUSTOMER TO SEND THE DEFECTIVE DEVICE FOR EXAMINATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE. 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
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281173 | MAQUET EXTENSION DEVICE TO YUNO OR TABLE | ACCESSORIES, OPERATING-ROOM, TABLE, FWZ | FWZ | MAQUET GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |