FDA Adverse Event
Malfunction
Summary report: N
TELLIGENCE
MDR report key: 7937726
·
Received October 5, 2018
Report
- Report Number
- 7937726
- Event Type
- Malfunction
- Date Received
- October 5, 2018
- Date of Event
- July 5, 2018
- Report Date
- September 28, 2018
- Manufacturer
- ASCOM (US) INC.
- Product Code
- IQA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
CALL BELL SYSTEM FAILED IN UNIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 779329 | TELLIGENCE | SYSTEM, ENVIRONMENTAL CONTROL, POWERED | IQA | ASCOM (US) INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |