FDA Adverse Event
Malfunction
Summary report: N
POLY C-LARC-OMCP-VISUB (BH3000)
MDR report key: 2110004
·
Received May 16, 2011
Report
- Report Number
- 3003768277-2011-00379
- Event Type
- Malfunction
- Date Received
- May 16, 2011
- Report Date
- April 20, 2011
- Manufacturer
- PHILIPS HEALTHCARE
- Product Code
- IZF
- PMA / PMN Number
- K925302
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE INVESTIGATION IS STILL ONGOING ON THIS EVENT. WHEN THE INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE IS NO FLUORO SOMETIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLY C-LARC-OMCP-VISUB (BH3000) | IZF | PHILIPS HEALTHCARE | 72242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |