FDA Adverse Event
Malfunction
Summary report: N
BV300
MDR report key: 1802450
·
Received August 9, 2010
Report
- Report Number
- 3003768277-2010-00148
- Event Type
- Malfunction
- Date Received
- August 9, 2010
- Date of Event
- July 1, 2010
- Report Date
- July 12, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZL
- PMA / PMN Number
- K953910
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD, RESULTS, AND 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 KEEPS FREEZING UP WHILE SCREENING AND THERE IS A BURNING ODOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BV300 | IZL (MOBILE X-RAY SYSTEM) | IZL | PHILIPS MEDICAL SYSTEMS | 71816 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |