FDA Adverse Event
Malfunction
Summary report: N
INFINIA HAWKEYE CAMERA
MDR report key: 16701063
·
Received April 7, 2023
Report
- Report Number
- 16701063
- Event Type
- Malfunction
- Date Received
- April 7, 2023
- Date of Event
- February 3, 2023
- Report Date
- March 23, 2023
- Manufacturer
- GE HEALTHCARE MANUFACTURING LLC
- Product Code
- KPS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
THE COMPUTER ON GAMMA CAMERA NOT FUNCTIONING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1730562 | INFINIA HAWKEYE CAMERA | SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION | KPS | GE HEALTHCARE MANUFACTURING LLC | INFINIA 621 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |