FDA Adverse Event
Malfunction
Summary report: N
PMX-2000
MDR report key: 84330
·
Received April 10, 1997
Report
- Report Number
- 1220984-1997-00006
- Event Type
- Malfunction
- Date Received
- April 10, 1997
- Date of Event
- March 7, 1997
- Report Date
- April 3, 1997
- Manufacturer
- LORAD CORP.
- Product Code
- KXJ
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE TECHNICIAN WAS BACKING THE UNIT UP AND ALLEGEDLY THE SPEED OF THE UNIT SUDDENLY CHANGED RESULTING IN HER BEING PUSHED INTO THE WALL. REPORTEDLY, THE UNIT STOPPED. THE TECHNICIAN REPORTEDLY INJURED HER BACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMX-2000 | RADIOGRAPHY | KXJ | LORAD CORP. | PMX-2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Other |