FDA Adverse Event
Other
Summary report: N
ECHO TABLE
MDR report key: 2033284
·
Received March 15, 2011
Report
- Report Number
- 1932056-2011-00003
- Event Type
- Other
- Date Received
- March 15, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 7, 2011
- Manufacturer
- MEDICAL POSITIONING, INC.
- Product Code
- IXR
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
MPI IS CURRENTLY WORKING WITH THE CUSTOMER TO HAVE THE DEVICE (OR AT MINIMUM THE AFFECTED PART(S)) RETURNED FOR EVAL. AT THE TIME OF THIS REPORT MPI WAS NOT ABLE TO FULLY EVALUATE THE DEVICE TO DETERMINE WHETHER THE DAMAGE WAS CAUSED BY MISUSE OR BY FAULTY DESIGN/MANUFACTURE. ONCE THE DEVICE IS RETURNED TO MPI A FULL INVESTIGATION WILL TAKE PLACE.
Description of Event or Problem · 1
A PT FELL OFF THE TABLE AND STRUCK HER HEAD AGAINST THE FLOOR AS A RESULT OF A WELD BREAKING FREE FROM THE STRUCTURE OF THE FRAME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHO TABLE | ECHO TABLE | IXR | MEDICAL POSITIONING, INC. | 2172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |