FDA Adverse Event
Malfunction
Summary report: N
KINAIR III
MDR report key: 3760761
·
Received April 2, 2014
Report
- Report Number
- 3760761
- Event Type
- Malfunction
- Date Received
- April 2, 2014
- Date of Event
- March 9, 2014
- Report Date
- April 2, 2014
- Manufacturer
- ARJOHUNTLEIGH INC.
- Product Code
- INX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- RI, US
Narratives
Description of Event or Problem · 1
APPROXIMATELY FIVE MINUTES AFTER PLACING PATIENT IN TRENDLENBURG POSITON FOR PROCEDURE THE BED DROPPED AND A LARGE METAL PIECE CAME FLYING OUT FROM UNDER THE BED. BED WAS CHANGED IMMEDIATELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 196732 | KINAIR III | BED | INX | ARJOHUNTLEIGH INC. | KASK00719 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR |