MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-12-23 for SYMMETRY PLUS PATIENT ROOM RECLINER -WALL SAVER MODEL 3500-000-730 * manufactured by Stryker Medical.
[20742458]
The patient was sleeping on the recliner on the reclined-and-seat-forward position which keeps it reclined. When the patient sat up to cough the whole chair leaned forward and the patient fell off. The patient received a laceration under his right eye from his glasses and an abrasion on his head. ======================health professional's impression======================on the reclined-and-seat-forward position the center of gravity of the chair system is when the patient is shifted forward. If a patient sits up, even if the patient is not too heavy, the center of gravity moves to the front wheels causing the whole chair assembly to tilt forward. This risk is not mentioned in the safety hazards section of the operator's manual.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1939300 |
| MDR Report Key | 1939300 |
| Date Received | 2010-12-23 |
| Date of Report | 2010-12-23 |
| Date of Event | 2010-12-09 |
| Report Date | 2010-12-23 |
| Date Reported to FDA | 2010-12-23 |
| Date Added to Maude | 2010-12-28 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY PLUS PATIENT ROOM RECLINER -WALL SAVER MODEL |
| Generic Name | RECLINING CHAIR, MOBILE |
| Product Code | FRJ |
| Date Received | 2010-12-23 |
| Model Number | 3500-000-730 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PATIENT |
| Device Availability | Y |
| Device Age | 1.5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER MEDICAL |
| Manufacturer Address | 3800 E. CENTRE AVE. PORTAGE MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-12-23 |