FDA Adverse Event
Malfunction
Summary report: N
PULMONARY FUNCTION LABORATORY
MDR report key: 50441
·
Received November 14, 1996
Report
- Report Number
- 2050001-1996-00012
- Event Type
- Malfunction
- Date Received
- November 14, 1996
- Date of Event
- October 11, 1996
- Report Date
- November 13, 1996
- Manufacturer
- SENSOR MEDICS CORP.
- Product Code
- BZC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE COMPUTER TERMINAL (S/N 1609-0214) FOR THE MODEL 2180 "SMOKED" ACCORDING TO THE USER. NO PTS WERE INVOLVED AND THERE WERE NO INJURIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULMONARY FUNCTION LABORATORY | PULMONARY FUNCTION TESTER | BZC | SENSOR MEDICS CORP. | 2180 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |