FDA Adverse Event
Malfunction
Summary report: N
2800
MDR report key: 2041461
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02724
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION AND WAS UNABLE TO DUPLICATE THE PROBLEM. THE CONNECTIONS TO THE COLLIMATOR INTERFACE AND THE PS4 WERE RESEATED. THE TOWER WAS BOOTED UP TEN TIMES WITHOUT FAILURE. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 2800 SYSTEM TOWER WOULD NOT BOOT UP. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 2800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |