MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-23 for SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER manufactured by Sechrist Industries, Inc..
[83360371]
Patient Sequence No: 1, Text Type: N, H10
[83360372]
During testing of the hyperbaric chamber, it was noted that the chamber was exhibiting erratic flow during the initial stages of compression until the chamber was up to pressure. In addition, when the user tried to initiate an emergency decompression, the chamber was slow to decompress. Inspection by the manufacturer rep noted excessive clogging of the chamber exhaust filter screen. It was noted that the filter was not completely removed and cleaned on both sides during the standard semi-annual chamber inspection. Biomedical reviewed incident and implemented an immediate change in the process of cleaning the exhaust filters. Biomedical changed the process to include complete removal and cleaning of the main exhaust filter screen. Biomedical also in consultation with the manufacturer on the filter screen size to determine whether or not the fine mesh screens are appropriate for he increased flow in theses larger chambers. Biomedical to increase monitoring of these filters to determine level of clogging in-between inspections. Manufacturer response for hyperbaric chamber, (brand not provided) (per site reporter). Manufacturer reported condition of filter and is consulting with in-house biomedical on corrective action. In-house cleaning procedure implemented to prevent future occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6812617 |
| MDR Report Key | 6812617 |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-15 |
| Date of Event | 2017-08-11 |
| Report Date | 2017-08-15 |
| Date Reported to FDA | 2017-08-15 |
| Date Reported to Mfgr | 2017-08-15 |
| Date Added to Maude | 2017-08-23 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| 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 | SECHRIST 3600E/ER MONOPLACE HYPERBARIC CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2017-08-23 |
| Model Number | 3600E |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 10 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 E. LA PALMA AVE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-23 |