FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2041021
·
Received March 23, 2011
Report
- Report Number
- 1720753-2011-02315
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- March 18, 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
A MFR'S SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE REP RESET THE X-RAY SECURITY SWITCH. THE POWER SUPPLY WAS ADJUSTED. THE GENERATOR INTERFACE PRINTED CIRCUIT BOARD WAS RE-SEATED. THE FOOT PEDAL WAS REPLACED. THE SYSTEM IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD NOT SAVE IMAGES FROM THE HAND CONTROL OR C-ARM INTERMITTENTLY. 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 |