FDA Adverse Event
Malfunction
Summary report: N
HAUSTED VIDEO IMAGING CHAIR
MDR report key: 1271751
·
Received November 18, 2008
Report
- Report Number
- 1043572-2008-00020
- Event Type
- Malfunction
- Date Received
- November 18, 2008
- Date of Event
- October 15, 2008
- Report Date
- November 17, 2008
- Manufacturer
- STERIS CORPORATION - MONTGOMERY
- Product Code
- FZK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
A STERIS SERVICE TECHNICIAN INSPECTED THE CHAIR, WHICH WAS MANUFACTURED IN 1995. INSPECTION OF THE CHAIR SHOWED EXTENSIVE CORROSION AND THAT THE GAS SPRING CONNECTED TO THE CHAIR BACK SECTION SHEARED OFF AT THE WELD WHERE IT ATTACHED TO THE SEAT ASSEMBLY. THE CHAIR WAS MAINTAINED BY HOSPITAL'S MAINTENANCE PERSONNEL, WHO INDICATED THAT SUCH EQUIPMENT IS NOT INCLUDED ON A PREVENTIVE MAINTENANCE PLAN AND THAT THEY PERFORM MAINTENANCE ON AN "AS NEEDED" BASIS WHEN A UNIT BREAKS. THE HOSPITAL REPORTED THAT THE PATIENT WAS NOT INJURED FROM THE FALL.
Description of Event or Problem · 1
WHILE THE HOSPITAL STAFF WAS PREPARING TO TRANSFER A PATIENT FROM A VIDEO IMAGING CHAIR, THE BACK SECTION OF THE CHAIR BROKE AND THE PATIENT FELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HAUSTED VIDEO IMAGING CHAIR | MANUAL OPERATING CHAIRS AND ACCESSORIES | FZK | STERIS CORPORATION - MONTGOMERY | 2661765 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |