FDA Adverse Event
Malfunction
Summary report: N
CT9000 BASIC SYSTEM
MDR report key: 1070628
·
Received July 1, 2008
Report
- Report Number
- 1518293-2008-00216
- Event Type
- Malfunction
- Date Received
- July 1, 2008
- Date of Event
- June 10, 2008
- Report Date
- June 4, 2008
- Manufacturer
- LIEBEL-FLARSHEIM CO.
- Product Code
- DXT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURING INVESTIGATION PENDING, WHEN INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SENT.
Description of Event or Problem · 1
BIO MED CUSTOMER REPORTED THAT THE COLUMN POST MOUNTED ON THE VERTICAL COLUMN BROKE AND THE LATERAL ARM FELL BUT WAS CAUGHT BY THE CT TECHNOLOGIST. CT TECH REPORTED THERE WAS NO INJURIES TO HER OR TO THE FEMALE PATIENT WHO WAS HAVING A CT OF THE ABDOMEN/PELVIS. SHE REPORTED THAT LATERAL ARM BROKE LOOSE WHEN SHE WAS PULLING THE INJECTOR CLOSER TO THE TABLE. SHE WAS ABLE TO CATCH AND HOLD THE INJECTOR WITH THE HELP OF THE INJECTORS ELECTRICAL CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CT9000 BASIC SYSTEM | POWER INJECTOR SYSTEM | DXT | LIEBEL-FLARSHEIM CO. | CT9000ADV | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |