FDA Adverse Event
Injury
Summary report: N
PROSPEED
MDR report key: 3865384
·
Received May 28, 2014
Report
- Report Number
- 9613445-2014-00104
- Event Type
- Injury
- Date Received
- May 28, 2014
- Date of Event
- April 28, 2014
- Report Date
- April 28, 2014
- Manufacturer
- GE HANGWEI MEDICAL SYSTEMS CO., LTD.
- Product Code
- JAK
- PMA / PMN Number
- K944013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PT IDENTIFIER WAS NOT PROVIDED. INITIAL REPORTER LAST NAME AND EMAIL WERE NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT'S HAND WAS INJURED WHEN SHE WAS MOVED TO THE CRADLE AND SLID TOWARDS THE GANTRY. STITCHES WERE ADMINISTERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 314215 | PROSPEED | SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED | JAK | GE HANGWEI MEDICAL SYSTEMS CO., LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other |