FDA Adverse Event
Malfunction
Summary report: N
OVERHEAD COUNTERPOISE SYSTEM
MDR report key: 176079
·
Received July 6, 1998
Report
- Report Number
- 2520313-1998-00033
- Event Type
- Malfunction
- Date Received
- July 6, 1998
- Date of Event
- May 21, 1998
- Report Date
- June 19, 1998
- Manufacturer
- F. WALTER HAENEL GMBH
- Product Code
- DXT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
HOSPITAL PERSONNEL REPORT THAT THE OVERHEAD COUNTERPOISE SYSTEM POST BROKE ALLOWING THE ARM THAT MOUNTS THE INJECTOR HEAD TO DROP INTO THE TECHNOLOGIST'S ARMS. NO INJURY OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVERHEAD COUNTERPOISE SYSTEM | OVERHEAD COUNTERPOISE SYSTEM | DXT | F. WALTER HAENEL GMBH | OCS115 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |