MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-10-26 for 3600E HBO CHAMBER, 36IN, ELECTRONIC CONTROL manufactured by Sechrist Industries, Inc..
[1664705]
Patient's first treatment and was taught how to clear ears. Twelve minutes into treatment, going down to pressure and compressing at 1. 0psi/minute heading toward 2ata. When the chamber got to 1. 52ata, it suddenly went back up to 1. 20ata. Then it went from 1. 20ata back to 1. 52ata in 5 seconds. This appeared to cause ear pain to the pt as the pt grabbed her head. Attendant set the pressure dow to 1. 10ata to stop the chamber pressure from elevating. The new set pressure was at 1. 10ata on the dial and the pressure continued going up. It finally stopped at 1. 57ata and then started coming down at a normal rate, slowly, at 1psi/minute. The doctor checked the pt after the pt was removed from the chamber and said pt had a teeds reading of t3 on the right ear.
Patient Sequence No: 1, Text Type: D, B5
[8914086]
Device failure related to loss of pressure at user facility. Device requires 45 to 70 psi pressure. Pressure reading at the main gauge read 40 psi.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2010-00030 |
| MDR Report Key | 1889819 |
| Report Source | 06 |
| Date Received | 2010-10-26 |
| Date of Report | 2010-10-26 |
| Date of Event | 2010-09-27 |
| Date Facility Aware | 2010-09-27 |
| Date Mfgr Received | 2010-09-27 |
| Date Added to Maude | 2011-02-24 |
| 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 EAST 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 EAST 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 | 3600E HBO CHAMBER, 36IN, ELECTRONIC CONTROL |
| Generic Name | 3600E |
| Product Code | CBF |
| Date Received | 2010-10-26 |
| Model Number | 3600E |
| Catalog Number | 3600E |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | ANAHEIM CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-26 |