FDA Adverse Event
Malfunction
Summary report: N
OVERHEAD COUNTERPOISE SYSTEM
MDR report key: 287197
·
Received July 24, 2000
Report
- Report Number
- 2520313-2000-00008
- Event Type
- Malfunction
- Date Received
- July 24, 2000
- Date of Event
- June 13, 2000
- Report Date
- July 20, 2000
- Manufacturer
- F. WALTER HANEL, GMBH
- Product Code
- DXT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSP REPORTED THE VERTICAL ARM AND THE HORIZONTAL ARM SEPARATED ON THE OVERHEAD COUNTERPOISE SYSTEM. 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 |