FDA Adverse Event
Other
Summary report: N
BUCKYDIAGNOST
MDR report key: 1914384
·
Received November 18, 2010
Report
- Report Number
- 3003768251-2010-00203
- Event Type
- Other
- Date Received
- November 18, 2010
- Date of Event
- October 2, 2008
- Report Date
- October 2, 2008
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- KPR
- PMA / PMN Number
- K945278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SERVICE MANUALS SPECIFY ROUTINE CLEANING OF THE CEILING SUSPENSION AND THE RAILS TO PREVENT THE ACCUMULATION OF DUST TO BUILD UP ON THE SYSTEM. THE CLEANING HISTORY OF THIS SYSTEM'S CEILING SUSPENSION AND RAILS IS UNK. (B)(4).
Description of Event or Problem · 1
THE CUSTOMER ALLEGED THE SUPPORT ROLLERS (BEARINGS) OF THE CEILING SUSPENSION WERE CAUSING THE ALUMINUM CEILING RAILS TO FLAKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUCKYDIAGNOST | KPR | PHILIPS MEDICAL SYSTEMS DMC GMBH | 70412 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |