FDA Adverse Event
Injury
Summary report: N
CT LIGHTSPEED VCT
MDR report key: 3888001
·
Received June 3, 2014
Report
- Report Number
- 2126677-2014-00009
- Event Type
- Injury
- Date Received
- June 3, 2014
- Date of Event
- April 25, 2014
- Report Date
- May 5, 2014
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- JAK
- PMA / PMN Number
- K040372
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A HOLE WAS MADE ON THE WRONG SIDE OF THE PT'S SKULL DUE TO MISINTERPRETATION OF IMAGING ORIENTATION. FURTHER ANALYSIS REVEALED THAT THE IMAGED WERE TAKEN IMPROPERLY, SUCH THAT THE TECHNICIAN DID NOT POSITION THE PT TO MATCH THE SELECTED PROTOCOL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 325540 | CT LIGHTSPEED VCT | COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | GE MEDICAL SYSTEMS, LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Other |