MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-08-27 for HYPERBARIC CHAMBER 3200 manufactured by Sechrist Industries, Inc..
[19247138]
Three pts experienced auditory seizures within the last 2 weeks. All 3 pts involved reportedly do not have any seizure history. One reported seizure turned into grand mal seizure. The chamber was depressurized and the pt was sent to the er. In the other two seizures, the chamber was compressed to air and within 5 minutes the pt's hearing came back and the seizure stopped. Both treatments were stopped.
Patient Sequence No: 1, Text Type: D, B5
[19328234]
Pt info outcome and any add'l info will be provided upon receipt from user facility.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2010-00025 |
| MDR Report Key | 1824586 |
| Report Source | 06 |
| Date Received | 2010-08-27 |
| Date of Report | 2010-08-27 |
| Date of Event | 2010-07-29 |
| Date Facility Aware | 2010-07-29 |
| Date Added to Maude | 2010-09-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 4225 E LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer Phone | 7145798400 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 E LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2010-08-27 |
| Model Number | 3200 |
| Catalog Number | 3200 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-08-27 |