FDA Adverse Event
Malfunction
Summary report: N
PHILIPS PMX
MDR report key: 306637
·
Received November 27, 2000
Report
- Report Number
- 1220984-2000-00014
- Event Type
- Malfunction
- Date Received
- November 27, 2000
- Date of Event
- November 20, 2000
- Report Date
- November 27, 2000
- Manufacturer
- LORAD, A HOLOGIC COMPANY
- Product Code
- IZL
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE UNIT BEGAN TO EMIT SMOKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PHILIPS PMX | RADIOLOGIC | IZL | LORAD, A HOLOGIC COMPANY | PMX-2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |