FDA Adverse Event
Malfunction
Summary report: N
NA
MDR report key: 10441897
·
Received August 24, 2020
Report
- Report Number
- 10441897
- Event Type
- Malfunction
- Date Received
- August 24, 2020
- Date of Event
- July 22, 2020
- Report Date
- August 11, 2020
- Manufacturer
- GE VINGMED ULTRASOUND AS
- Product Code
- ITX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 0
THE TEE PROBE FAILED THE ELECTRICAL LEAK TEST ONE DAY, IT WAS NOT TAKEN OUT OF SERVICE, AND USED ON ANOTHER PATIENT ON ANOTHER DAY.
Description of Event or Problem · 1
THE TEE PROBE FAILED THE ELECTRICAL LEAK TEST ONE DAY, IT WAS NOT TAKEN OUT OF SERVICE, AND USED ON ANOTHER PATIENT ON ANOTHER DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 909738 | NA | TRANSDUCER, ULTRASONIC, DIAGNOSTIC | ITX | GE VINGMED ULTRASOUND AS | 6VT-D |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27010 DA |