FDA Adverse Event
Malfunction
Summary report: N
OVERHEAD COUNTERPOISE SYSTEM
MDR report key: 240183
·
Received September 9, 1999
Report
- Report Number
- 2520313-1999-00028
- Event Type
- Malfunction
- Date Received
- September 9, 1999
- Date of Event
- August 16, 1999
- Report Date
- September 3, 1999
- Manufacturer
- F. WALTER HANEL GMBH
- Product Code
- DXT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSP REPORTED THE FLEX JOINT ON THE OVERHEAD COUNTERPOISE SYSTEM BROKE CAUSING THE INJECTOR HEAD TO FALL. THE INJECTOR HEAD CABLE KEPT THE HEAD FROM HITTING THE FLOOR. NO INJURY 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 |