FDA Adverse Event
Other
Summary report: N
OVERHEAD COUNTERPOISE SYSTEM
MDR report key: 242753
·
Received September 28, 1999
Report
- Report Number
- 2520313-1999-00029
- Event Type
- Other
- Date Received
- September 28, 1999
- Date of Event
- August 24, 1999
- Report Date
- September 24, 1999
- Manufacturer
- F. WALTER HANEL, GMBH
- Product Code
- DXT
- Removal / Correction Number
- NONE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
USER FACILITY REPORTED THE RADIOLOGIST ROTATED THE C-ARM INTO THE HORIZONTAL ARM. THE HORIZONTAL ARM JAMMED THE C-ARM AND CAUSED AN ERROR IN THE SIEMENS SYSTEM. THE ERROR WAS RESET AND THE C-ARM WAS STILL LOCKED/JAMMED AGAINST THE HORIZONTAL ARM. THE RADIOLOGIST MANUALLY PULLED THE LEAD SHIELD AND ARM, AND THE OVERHEAD COUNTERPOISE SYSTEM FLANGE BROKE CAUSING THE ENTIRE ARM ASSEMBLY TO SLOWLY DROP. THE RADIOLOGIST AND TECHNICIANS WERE ABLE TO CATCH THE SYSTEM AND MENUEVER IT TO THE FLOOR AWAY FROM THE PT. NO INJURRY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVERHEAD COUNTERPOISE SYSTEM | OVERHEAD COUNTERPOISE SYSTEM | DXT | F. WALTER HANEL, GMBH | OCS115 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |