MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for HYPERBARIC CHAMBER 3600ER-00 manufactured by Sechrist Industries, Inc..
[70774867]
Patient Sequence No: 1, Text Type: N, H10
[70774868]
Hyperbaric chamber reached set pressure after 25 minutes. One hour into treatment, pressure was not maintained. Pressure dropped and patient was removed from chamber. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431426 |
| MDR Report Key | 6431426 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-17 |
| Date of Event | 2016-04-15 |
| Report Date | 2017-03-17 |
| Date Reported to FDA | 2017-03-17 |
| Date Reported to Mfgr | 2017-03-17 |
| Date Added to Maude | 2017-03-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2017-03-24 |
| Model Number | 3600ER-00 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 EAST LA PALMA AVE. ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |