FDA Adverse Event
Malfunction
Summary report: N
MODEL 500E
MDR report key: 57308
·
Received December 10, 1996
Report
- Report Number
- 1216774-1996-00005
- Event Type
- Malfunction
- Date Received
- December 10, 1996
- Manufacturer
- COROMETRICS MEDICAL SYSTEMS, INC.
- Product Code
- FLS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- RESPIRATORY THERAPIST
Narratives
Description of Event or Problem · 1
THE MONITOR DID NOT PRODUCE AN AUDIO ALARM. THERE WAS NO DEATH OR SERIOUS INJURY REPORTED IN CONNECTION WITH THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL 500E | INFANT APNEA MONITOR | FLS | COROMETRICS MEDICAL SYSTEMS, INC. | 500E | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |