FDA Adverse Event
Malfunction
Summary report: N
BUCKY DIAGNOST
MDR report key: 2043395
·
Received February 25, 2011
Report
- Report Number
- 3003768251-2011-00021
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Report Date
- January 31, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- KPR
- PMA / PMN Number
- K945278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS CURRENTLY ONGOING AND CONCLUSIONS WILL BE SENT IN A FOLLOW UP REPORT BEFORE 04/29/2011.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE BOLTS HOLDING THE X-RAY TUBE WERE LOOSE AND THE X-RAY TUBE MOVES SLIGHTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUCKY DIAGNOST | KPR | PHILIPS MEDICAL SYSTEMS DMC GMBH | 704030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |