FDA Adverse Event
Other
Summary report: N
OVERHEAD TUBE SUPPORT (OTS)
MDR report key: 187015
·
Received September 10, 1998
Report
- Report Number
- 1451011-1998-00001
- Event Type
- Other
- Date Received
- September 10, 1998
- Date of Event
- June 24, 1998
- Report Date
- September 4, 1998
- Manufacturer
- ACOMA MEDICAL IMAGING, INC.
- Product Code
- IYB
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON 6-24-1998, THE END PLATE ON THE LOWER TUBE COLUMN ON THE OTS BROKE FREE FROM THE COLUMN, ALLOWING THE X-RAY TUBE/COLLIMATOR ASSEMBLY TO HANG FROM THE HIGH TENSION/POWER CABLES. UPON INVESTIGATION IT WAS DISCOVERED THAT THE WELDS HAD BEEN GROUND DOWN IN THE FINISHING PROCESS AND ONLY 1 WELDING PLUG HAD BEEN WELDED INSTEAD OF 4.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OVERHEAD TUBE SUPPORT (OTS) | CEILING MOUNTED TUBE SUPPORT | IYB | ACOMA MEDICAL IMAGING, INC. | A-9020009 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Other |