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 2004-12-16 for HAUSTED ALL PRUPOSE CHAIR 2662795 manufactured by Steris Corporation - Montgomery.
[16140069]
The pt quadraplegic, was being transferred by 2 staff members, using a sheet transfer, from a hospital bed to the apc chair when the pt's arm fell to the side. Staff member leaned over to secure arm. Because of their size, staff had their knee braced up on chair, accidentally hit the brake release on the apc chair, which then separated from the hospital bed and the pt fell through, striking their head on the floor. Pt was alert for some time, then slipped into unconsciousness and never recovered. Pt died at hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2004-00006 |
| MDR Report Key | 560954 |
| Report Source | 05,06,07 |
| Date Received | 2004-12-16 |
| Date of Report | 2004-12-15 |
| Date of Event | 2004-11-28 |
| Date Facility Aware | 2004-11-29 |
| Report Date | 2004-12-15 |
| Date Mfgr Received | 2004-12-07 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 2004-12-23 |
| 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 |
| 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 ALL PRUPOSE CHAIR |
| Generic Name | MANUAL OPERATING CHAIR AND ACCESSORIES |
| Product Code | FZK |
| Date Received | 2004-12-16 |
| Model Number | 2662795 |
| Catalog Number | 2662795 |
| Lot Number | NA |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 8.5 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 550662 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | * MONTGOMERY AL 36109 US |
| Baseline Brand Name | HAUSTED ALL PURPOSE CHAIR |
| Baseline Generic Name | MANUAL OPERATING CHAIR AND ACCESSORIES |
| Baseline Model No | 2662795 |
| Baseline Catalog No | 2662795 |
| Baseline ID | NA |
| Baseline Device Family | MANUAL OPERATING CHAIR AND ACCESSORIES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 3 | 1. Death | 2004-12-16 |