FDA Adverse Event
Other
Summary report: N
ECHOBED
MDR report key: 2354841
·
Received November 9, 2011
Report
- Report Number
- 1932056-2011-00006
- Event Type
- Other
- Date Received
- November 9, 2011
- Date of Event
- November 7, 2011
- Report Date
- November 9, 2011
- Manufacturer
- MEDICAL POSITIONING, INC.
- Product Code
- LGX
- 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 HAD NOT RECEIVED THE PART(S) AND THUS 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
AN EMPLOYEE OF THE HOSP WAS PULLING ON THE TABLE WHEN A WELDMENT BROKE WHICH CAUSED THE HEAD END OF THE TABLE TO RAPIDLY FALL TO THE GROUND. WHILE NO PT WAS PRESENT DURING THE INCIDENT, IF A PT HAD BEEN ON THE PRODUCT WHEN THIS HAPPENED, THERE IS A POSSIBILITY OF SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ECHOBED | ECHOBED | LGX | MEDICAL POSITIONING, INC. | 1233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |