FDA Adverse Event
Malfunction
Summary report: N
BURKHART ROENTGEN, INC.
MDR report key: 91555
·
Received August 15, 1994
Report
- Report Number
- 91555
- Event Type
- Malfunction
- Date Received
- August 15, 1994
- Date of Event
- March 18, 1994
- Report Date
- March 24, 1994
- Manufacturer
- BURKHART ROENTGEN, INC.
- Product Code
- IWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
THE X-RAY SHIELD SUSPENDED ABOVE TABLE FELL AT TEH FOOT OF THE TABLE. PT WAS NOT INJURED. THE SHIELD FELL AS IT WAS BEING MOVED. WELD BROKE AT THE BASE OF THE POST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BURKHART ROENTGEN, INC. | X-RAY SHIELD | IWQ | BURKHART ROENTGEN, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Other |