MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-05-13 for STRETCHAIR PT TRANSFER SYSTEMS MC-400VL 0045-0400V1 manufactured by Stretchair Pts.
[20205198]
Patient was sitting in critical care safety chair, secured by velcro waistband. Patient was restless and apparently worked velcro strap loose. Patient fell forward and struck head on floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 446469 |
| MDR Report Key | 446469 |
| Date Received | 2003-05-13 |
| Date of Report | 2003-02-21 |
| Date of Event | 2003-02-07 |
| Date Facility Aware | 2003-02-07 |
| Report Date | 2003-02-21 |
| Date Reported to FDA | 2003-02-21 |
| Date Reported to Mfgr | 2003-02-21 |
| Date Added to Maude | 2003-03-10 |
| 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 | STRETCHAIR PT TRANSFER SYSTEMS |
| Generic Name | TRANSPORT STRETCHER/CHAIR |
| Product Code | IQC |
| Date Received | 2003-05-13 |
| Model Number | MC-400VL |
| Catalog Number | 0045-0400V1 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 20 MO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 435438 |
| Manufacturer | STRETCHAIR PTS |
| Manufacturer Address | 8110 ULMERTON ROAD LARGO FL 33771 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2003-05-13 |