FDA Adverse Event
Malfunction
Summary report: N
OMNI DIAGNOST
MDR report key: 1912447
·
Received November 11, 2010
Report
- Report Number
- 3003768277-2010-00295
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- October 15, 2010
- Report Date
- October 15, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- JAA
- PMA / PMN Number
- K982993
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(EVAL METHOD, RESULTS, CONCLUSIONS): THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THIS X-RAY SYSTEM HAD ITS RADIOSCOPY STOP IN THE MIDDLE OF THE EXAMINATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OMNI DIAGNOST | JAA (X-RAY FLUOROSCOPIC, IMAGE INTENSIFIED, SYSTEM) | JAA | PHILIPS MEDICAL SYSTEMS | 708023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |