MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-08-02 for 3600E HYPERBARIC CHAMBER manufactured by Sechrist Industries, Inc..
[1358585]
Chamber went into alarm mode immediately after turning chamber on. Alarm code e302 displayed, indicating pressure transducer issue. Hard reset done per ifus, but condition not changed. New ecm board cq 306 installed, calibrated and performance verified. Chamber restored to service.
Patient Sequence No: 1, Text Type: D, B5
[8790993]
Facility has previous history of electrical surges which required chamber resetting. Service technician advised customer to install surge protectors. The original system board was replaced in the field. System board was investigated and could not find any issues with the board.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2010-00016 |
| MDR Report Key | 1785630 |
| Report Source | 06 |
| Date Received | 2010-08-02 |
| Date of Report | 2010-08-02 |
| Date of Event | 2008-05-05 |
| Date Reported to FDA | 2010-08-02 |
| Date Mfgr Received | 2008-05-09 |
| Device Manufacturer Date | 2008-01-29 |
| Date Added to Maude | 2011-12-28 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 4225 E. 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 E. LA PALMA AVE. |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3600E HYPERBARIC CHAMBER |
| Generic Name | MONOPLACE HYPERBARIC CHAMBER MODEL 3600E |
| Product Code | CBF |
| Date Received | 2010-08-02 |
| Model Number | 3600E |
| Catalog Number | 3600E |
| Operator | OTHER |
| 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 | 2010-08-02 |