FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9800
MDR report key: 1040776
·
Received May 9, 2008
Report
- Report Number
- 1720753-2008-21353
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 28, 2008
- Report Date
- May 7, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE SVC REP. REBOOTED SYSTEM 5 TIMES WITHOUT ERRORS. COULD NOT DUPLICATE STATED PROBLEM. PERFORMED BATTERY TEST USING CURRENT TEST PROCEDURES. SYSTEM OPERATING AS INTENDED.
Description of Event or Problem · 1
CUSTOMER REPORTED DURING FLUORO UNIT HAD NO IMAGE DISPLAY AND GIVES MA SENSOR FAILURE ERROR. PT INVOLVED, BUT NOT INJURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |