FDA Adverse Event
Malfunction
Summary report: N
CASUALTY SYSTEMS FOR RADIOGRAPHY
MDR report key: 2493342
·
Received March 12, 2012
Report
- Report Number
- 3003768251-2012-00006
- Event Type
- Malfunction
- Date Received
- March 12, 2012
- Report Date
- February 12, 2012
- Manufacturer
- PHILIPS MEDICAL SYSTEMS DMC GMBH
- Product Code
- KPR
- PMA / PMN Number
- K945278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA. (B)(4).
Description of Event or Problem · 1
COMPLAINT REPORTED ABOUT A (VS) WALL STAND WHERE THE BUCKY UNIT FELL DOWN. NO PERSON WAS INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CASUALTY SYSTEMS FOR RADIOGRAPHY | KPR | PHILIPS MEDICAL SYSTEMS DMC GMBH | 720013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |