FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041118
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02354
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- June 14, 2010
- Report Date
- March 23, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE WIRE CRIMP ON THE CIRCUIT BREAKER WAS REPAIRED. THE SYSTEM BATTERIES WERE REPLACED AND ADJUSTED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM DISPLAYED A PER-CHARGE VOLTAGE ERROR MESSAGE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |