MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-01-22 for MIDLAND TILT TABLE 7195E manufactured by Sammons Preston.
[1315929]
Pt was in physical therapy on 'tilt machine' and had been placed in a horizontal position with straps loosened. Physical therapist turned away to request assistance, when the tilt machine malfunctioned and repositioned itself to a 15-10 degree angle allowing the pt to slide forward and fall on to the floor. Fall resulted in a laceration to the forehead requiring 9 sutures. A ct scan ruled out any fractures to pt's neck, etc. Biomed could not duplicate the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5014491 |
| MDR Report Key | 1588693 |
| Date Received | 2010-01-22 |
| Date of Report | 2010-01-22 |
| Date of Event | 2010-01-12 |
| Date Added to Maude | 2010-02-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIDLAND TILT TABLE |
| Generic Name | TILT TABLE |
| Product Code | JFB |
| Date Received | 2010-01-22 |
| Model Number | 7195E |
| ID Number | APPROX AGE > 5 YRS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAMMONS PRESTON |
| Manufacturer Address | BOLINGBROOK IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2010-01-22 |