MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-29 for GYROSTIM manufactured by Ultra Thera Technologies, Inc.
[45093332]
While at (b)(6), was inside the gyrostim machine for treatment, when the machine continuously went in one direction, which was not part of plan. When the doctor on hand told the machine to stop, the machine crashed instead of gliding to a stop. Neurological problems got worse as did problems with fatigue and stamina. Was laid up for a few weeks. Was also later told after doctor spoke with inventor that this could have been supposedly prevented with a short protocol check. I don't want this happening to more people. Supposedly, a button had been half pressed which caused machine to malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062224 |
| MDR Report Key | 5650750 |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-29 |
| Date of Event | 2014-11-04 |
| Date Added to Maude | 2016-05-12 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | GYROSTIM |
| Product Code | MHZ |
| Date Received | 2016-03-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ULTRA THERA TECHNOLOGIES, INC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-03-29 |