FDA Adverse Event
Other
Summary report: N
MODEL 500EXL
MDR report key: 177938
·
Received July 16, 1998
Report
- Report Number
- 1216774-1998-00015
- Event Type
- Other
- Date Received
- July 16, 1998
- Report Date
- July 15, 1998
- Manufacturer
- COROMETRICS MEDICAL SYSTEMS, INC.
- Product Code
- FLS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
MONITOR WAS RETURNED TO THE COROMETRICS FACTORY SERVICE DEPARTMENT FOR REPAIRS FOR THE SYMPTOM OF "AUDIBLE ALARM NOT WORKING." CUSTOMER COMPLAINT FILE WAS GENERATED INTERNALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODEL 500EXL | INFANT MONITOR | FLS | COROMETRICS MEDICAL SYSTEMS, INC. | 500EXL | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |