D
Patient 1
IT WAS REPORTED THAT IMAGES ON THE EXAM ROOM LIVE MONITOR WERE FLICKERING. THIS ISSUE MAY RESULT IN A DEGRADED IMAGE QUALITY THAT CAN PREVENT COMPLETION OF AN EXAM. NO PATIENT INJURY OR DEATH REPORTED.
MAUDE MDR 3829736
- MDR report key
- 3829736
- Report number
- 9611343-2014-00060
- Event key
- 0
- Event type
- 3
- Date of event
- 2014-02-25
- Date received
- 2014-03-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- JOY SONSALLA
- Address
- 3000 N. GRANDVIEW BLVD. WAUKESHA WI 53188 US
- Phone
- 262-262-2625
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ADVANTX | GENERATOR, HIGH-VOLTAGE, X-RAY | GE MEDICAL SYSTEMS SCS | IZO | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-03-26 | 0 |
Event Narratives#
N
Patient 1
INITIAL REPORTER LAST NAME AND EMAIL WERE NOT PROVIDED. THIS MALFUNCTION WAS DETERMINED TO BE REPORTABLE AS THIS SAME MALFUNCTION HAS PREVIOUSLY CONTRIBUTED TO A SERIOUS INJURY WITHIN THE LAST THREE YEARS. REFERENCE MDR 9611343-2011-00001. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.