FDA Adverse Event
Malfunction
Summary report: N
INNOVA 2100
MDR report key: 2547422
·
Received April 23, 2012
Report
- Report Number
- 9611343-2007-00086
- Event Type
- Malfunction
- Date Received
- April 23, 2012
- Date of Event
- September 26, 2007
- Report Date
- October 23, 2007
- Manufacturer
- GE MEDICAL SYSTEMS SCS
- Product Code
- MQB
- PMA / PMN Number
- K050489
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
CUSTOMER REPORTED THAT THE SYS LOCKS UP WITH "STOP SEQUENCE TIMED OUT" ERROR. SYS WAS REPORTEDLY UNABLE TO BE RESET AND HAD TO BE POWERED OFF/ON TO CLEAR THE ERROR. PT WAS MOVED TO ANOTHER ROOM IN ORDER TO COMPLETE THE EXAM. NO REPORTED PT INCIDENT. THE REPORTED CONDITION IS CONSISTENT WITH A KNOWN ISSUE REFERRED TO AS FCIB. GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A F/U REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INNOVA 2100 | VASCULAR X-RAY SYSTEM | MQB | GE MEDICAL SYSTEMS SCS | 5129703 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |