FDA Adverse Event
Malfunction
Summary report: N
BUCKY DIAGNOST TH
MDR report key: 2277072
·
Received September 29, 2011
Report
- Report Number
- 3003768251-2011-00070
- Event Type
- Malfunction
- Date Received
- September 29, 2011
- Report Date
- September 6, 2011
- Manufacturer
- PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH
- Product Code
- KPR
- PMA / PMN Number
- K945278
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- 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
THE CUSTOMER REPORTED THAT THE COVER FELL OFF WHEN HE WAS POSITIONING THE TUBE CRANE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BUCKY DIAGNOST TH | KPR | PHILIPS MEDICAL SYSTEMS GMBH DMC GMBH | 704030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |