MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-21 for STRYKER CARDIAC CHAIR 5050 manufactured by Stryker.
[38099458]
During patient transfer from bed to cardiac chair, the bed and chair separated and the patient fell to the floor. Staff involved indicated the bed and chair were in the "locked" position. Patient landed on her right side where she recently had a right femur fracture repair with hardware. X-rays showed a shift in the hardware (pins and plate).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5430844 |
| MDR Report Key | 5430844 |
| Date Received | 2016-01-21 |
| Date of Report | 2015-12-21 |
| Date of Event | 2015-12-05 |
| Date Facility Aware | 2015-12-05 |
| Report Date | 2015-12-21 |
| Date Reported to Mfgr | 2015-12-21 |
| Date Added to Maude | 2016-02-11 |
| 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 | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STRYKER CARDIAC CHAIR |
| Generic Name | CARDIAC CHAIR |
| Product Code | BYN |
| Date Received | 2016-01-21 |
| Model Number | 5050 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | 2525 AIRVIEW BOULEVARD KALAMAZOO MI 49002 US 49002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2016-01-21 |