MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-11-18 for HAUSTED VIDEO IMAGING CHAIR 2661765 manufactured by Steris Corporation - Montgomery.
[990745]
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.
Patient Sequence No: 1, Text Type: D, B5
[8174098]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1043572-2008-00020 |
| MDR Report Key | 1271751 |
| Report Source | 05,06,07 |
| Date Received | 2008-11-18 |
| Date of Report | 2008-11-17 |
| Date of Event | 2008-10-15 |
| Date Facility Aware | 2008-10-15 |
| Report Date | 2008-11-17 |
| Date Mfgr Received | 2008-10-16 |
| Device Manufacturer Date | 1995-01-02 |
| Date Added to Maude | 2009-11-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROBERT MCCALL |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal | 36109 |
| Manufacturer Phone | 3342133150 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAUSTED VIDEO IMAGING CHAIR |
| Generic Name | MANUAL OPERATING CHAIRS AND ACCESSORIES |
| Product Code | FZK |
| Date Received | 2008-11-18 |
| Model Number | 2661765 |
| Catalog Number | 2661765 |
| Lot Number | NA |
| ID Number | VIC429ST |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 156 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-11-18 |