FDA Adverse Event
Malfunction
Summary report: N
PMX-2000
MDR report key: 65736
·
Received January 31, 1997
Report
- Report Number
- 1217116-1997-90001
- Event Type
- Malfunction
- Date Received
- January 31, 1997
- Date of Event
- October 17, 1996
- Report Date
- January 23, 1997
- Manufacturer
- LORAD
- Product Code
- KXJ
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Location
- MS, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
WHILE THE TECHNICIAN BACKED THE UNIT THROUGH THE DOOR AND TURNED IT, THE UNIT ALLEGEDLY BEGAN TO INCREASE IN SPEED. TECHNICIAN RELEASED THE HANDLE, BUT THE UNIT ALLEGEDLY DID NOT STOP AND PUSHED THE TECHNICIAN INTO THE WALL AND THEN TO THE FLOOR. TECHNICIAN WAS TREATED FOR A MILD ABRASION TO THE RIGHT LOWER LEG.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PMX-2000 | RADIOGRAPHY | KXJ | LORAD | PMX-2000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR |