FDA Adverse Event
Malfunction
Summary report: N
CS 2
MDR report key: 176422
·
Received July 7, 1998
Report
- Report Number
- 1217116-1998-00016
- Event Type
- Malfunction
- Date Received
- July 7, 1998
- Date of Event
- June 1, 1998
- Report Date
- June 1, 1998
- Manufacturer
- PHILIPS SYSTEME MEDEZIN
- Product Code
- IYB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTEDLY, AS THE X-RAY TECH WAS MOVING THE OVERHEAD TUBE, ONE OF THE CABLE BRACKET HANGERS DETACHED FROM THE CS 2 X-RAY TUBE CEILING SUSPENSION AND ALLEGEDLY THE HANGER AND CABLING HOSE FELL STRIKING THE PT IN THE LEFT HIP WHICH WAS THE AREA OF HER BODY JUST X-RAYED. REPORTEDLY, THE PT EXPERIENCED PAIN IN THAT AREA BUT DID NOT REQUIRE MED ATTENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CS 2 | DIAGNOSTIC X-RAY TUBE MOUNT | IYB | PHILIPS SYSTEME MEDEZIN | 9896-010-06521 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |