FDA Adverse Event
Malfunction
Summary report: N
ALLEN - BEACH CHAIR (CAPTAIN'S CHAIR)
MDR report key: 1460466
·
Received August 18, 2009
Report
- Report Number
- 1460466
- Event Type
- Malfunction
- Date Received
- August 18, 2009
- Date of Event
- May 19, 2009
- Report Date
- August 17, 2009
- Manufacturer
- ALLEN MEDICAL SYSTEMS, INC.
- Product Code
- FWZ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
THE PATIENT WAS IN THE BEACH CHAIR WHEN IT WAS NOTICED THAT THE CHAIR BECAME DISCONNECTED FROM THE TABLE. TO CORRECT THE SITUATION, SEVERAL PEOPLE HELD THE PATIENT, (STILLSECURED TO THE BEACH CHAIR) UP FROM DROPPING. THESE PEOPLE WERE UNDER THE OPERATING ROOM TABLE, WHILE OTHERS REATTACHED THE DEVICE TO THE OPERATING ROOM TABLE. THE PATIENT WAS NOT INJURED. OUR BIOMEDICAL INVESTIGATION CONCLUDED THAT THIS IS A HUMAN FACTORS ISSUE BECAUSE THERE IS NO CLEAR INDICATION IF THE LATCH IS PROPERLY SECURED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALLEN - BEACH CHAIR (CAPTAIN'S CHAIR) | ACCESSORIES, OPERATING-ROOM, TABLE - MULTIPLE | FWZ | ALLEN MEDICAL SYSTEMS, INC. | OSCA4 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |