MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-06-11 for CHAMBER, HYPERBARIC 3300HR 3300HR-01-1 manufactured by Sechrist Industries, Inc..
[4751020]
During regularly scheduled testing the decompression time of the hyperbaric chamber was found to be 35 seconds from 6 psi to 5 psi. This is faster than the specification of 50 - 70 seconds.
Patient Sequence No: 1, Text Type: D, B5
[12273732]
The reported complaint that the chamber is compressing slower than specification and decompressing faster than specification was verified. The chamber was noted as compressing from 5 - 6 psi in 86 seconds, 14 - 15 psi in 85 seconds and from 25 -26 psi in 95 seconds. Decompression timing was recorded from 6 -5 psi in 35 seconds. Specification at a rate of 1 psi for compression or decompression is 50 - 70 seconds. Slow compression and/or decompression provides the patient with additional time to acclimate to the pressure and is not reportable. The decompression timing of 35 seconds could result in barotrauma which makes this reported failure reportable. The chamber was evaluated by a technician from the manufacturer. He found that the rate valve was out of calibration and required an adjustment. Upon adjusting the rate valve the timing of the chamber was tested and verified as being within specification. The cause of the rate valve going out of specification and increasing the decompression timing is unknown. The probable cause is drift.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2014-00019 |
| MDR Report Key | 3987508 |
| Report Source | 05,06 |
| Date Received | 2014-06-11 |
| Date of Report | 2014-06-11 |
| Date of Event | 2014-05-12 |
| Date Mfgr Received | 2014-05-12 |
| Device Manufacturer Date | 2013-10-18 |
| Date Added to Maude | 2014-08-20 |
| 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 Contact | MDR CONTACT |
| 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 | 2014-06-11 |
| Model Number | 3300HR |
| Catalog Number | 3300HR-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 | 2014-06-11 |