FDA Adverse Event
Malfunction
Summary report: N
BV PULSERA
MDR report key: 1912408
·
Received November 15, 2010
Report
- Report Number
- 3003768277-2010-00299
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 20, 2010
- Report Date
- October 20, 2010
- Manufacturer
- PHILIPS MEDICAL SYSTEMS
- Product Code
- IZL
- PMA / PMN Number
- K010435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(METHOD, RESULTS, CONCLUSIONS) - THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED, A F/U REPORT WILL BE SENT TO THE FDA. (B)(4).
Description of Event or Problem · 1
THIS X-RAY SYS SUDDENLY STOPPED WORKING DURING AN EXAM. A SYS REBOOT DID NOT BRING THE FLUOROSCOPY CAPABILITY BACK ON LINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BV PULSERA | IZL (MOBILE X-RAY SYSTEM) | IZL | PHILIPS MEDICAL SYSTEMS | 718093 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |