FDA Adverse Event
Malfunction
Summary report: N
NXT
MDR report key: 139781
·
Received December 22, 1997
Report
- Report Number
- 1528274-1997-00035
- Event Type
- Malfunction
- Date Received
- December 22, 1997
- Date of Event
- November 30, 1997
- Report Date
- December 18, 1997
- Manufacturer
- SMV INTERNATIONAL
- Product Code
- JWM
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FRAMES DISPLAYED AND PT'S NAME WRITTEN ARE DISCORDANT
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NXT | COMPUTER | JWM | SMV INTERNATIONAL | NXT | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |