FDA Adverse Event
Malfunction
Summary report: N
ELI 380
MDR report key: 20203397
·
Received September 12, 2024
Report
- Report Number
- 20203397
- Event Type
- Malfunction
- Date Received
- September 12, 2024
- Date of Event
- September 12, 2023
- Report Date
- March 6, 2024
- Manufacturer
- WELCH ALLYN, INC.
- Product Code
- DPS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ELI 380 | ELECTROCARDIOGRAPH | DPS | WELCH ALLYN, INC. | ELI 380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |