FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1173009
·
Received September 19, 2008
Report
- Report Number
- 1720753-2008-26109
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- September 4, 2008
- Report Date
- September 19, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REP RECEIVED AND REPLACED THE INTERCONNECT CABLE. HE TESTED THE SYSTEM, BUT HAD THE SAME SYMPTOMS. THE REP REPAIRED THE CONNECTION ON THE EMI SHIELD AT THE CCD CAMERA. THE UNIT IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED NOT GETTING ANY IMAGES WHEN TAKING X-RAYS. THE SYSTEM BEEPS AND SOUNDS LIKE IT IS TAKING X-RAYS, BUT THERE ARE NO IMAGES DISPLAYING ON THE MONITOR. NO PATIENT INJURIES WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |