FDA Adverse Event
Malfunction
Summary report: N
HDX TWINSPEED
MDR report key: 1361340
·
Received January 14, 2009
Report
- Report Number
- 2183553-2009-00001
- Event Type
- Malfunction
- Date Received
- January 14, 2009
- Date of Event
- November 10, 2008
- Report Date
- November 10, 2008
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- LNH
- PMA / PMN Number
- K012200
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION IS ONGOING.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE CUSTOMER WAS DOING A STRESS PERFUSION WITH CONTRAST EXAM, THE WHOLE HEART APPEARED BRIGHT IN THE IMAGE. THE RADIOLOGIST FELT THAT THIS IMAGE ARTIFACT COULD BE MISINTERPRETED AS A CARDIAC INFECTION. NO MISDIAGNOSIS OR MISTREATMENT OCCURRED. THE PATIENT WAS RESCANNED SUCCESSFULLY WITHOUT ANY FURTHER ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HDX TWINSPEED | LNH | GE MEDICAL SYSTEMS, LLC | 2294302 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |