MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-03 for CHAMBER, HYPERBARIC 3300H 3300H-01-1 manufactured by Sechrist Industries, Inc..
[4635787]
During clinical use the chamber decompressed from 2. 0 at to 0 ata in 6. 5 minutes. Testing of the chamber was done, by the center staff, after the pt was removed and the failure was duplicated. Info provided by the center states that the pt was not injured. They are reported as doing "fine".
Patient Sequence No: 1, Text Type: D, B5
[12218193]
The reported complaint that the chamber is decompressing faster than spec was verified. The decompression timing from 2. 0 ata to 0 ata in 6. 5 minutes could be a potential safety issue if the pt has lung disease and holds their breath. This could result in gas becoming trapped in their chest. The chamber was evaluated by a technician from the mfr. He found that the rate valve ws out of calibration and required an adjustment. A note was included in the report stating that the issue was resolved. The cause of the rate valve going out of spec and increasing the decompression timing is unk. The probable cause is drift.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2014-00025 |
| MDR Report Key | 3983290 |
| Report Source | 05,06 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-05-23 |
| Date Mfgr Received | 2014-06-05 |
| Device Manufacturer Date | 2013-08-08 |
| Date Added to Maude | 2014-08-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHAMBER, HYPERBARIC |
| Generic Name | HYPERBARIC MONOPLACE CHAMBER |
| Product Code | CBF |
| Date Received | 2014-07-03 |
| Model Number | 3300H |
| Catalog Number | 3300H-01-1 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2014-07-03 |