MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2017-04-13 for HYPERBARIC CHAMBER 3600E manufactured by Sechrist Industries, Inc..
[72812509]
On 4/21/2016 a sechrist technician was dispatched onsite. Technician verified control system regulator set to 40. 0psi, checked timing and found it was out of specification. Technician replaced i/p regulator and chamber performed as designed. This report is in response to (b)(4) that sechrist received on 3/27/2017. The chamber is designed to fail in safe state. Sechrist electronic control module configuration & diagnostics manual, section 8. 12. Category 11 - system errors and alarms, page 20 of 80 states: the "safe state/inoperative" condition is caused by critical system error or an operating condition that renders unsafe. When one or both of the mcus do not respond to the external watchdog timer, the watchdog timer will activate the safety solenoid to drive the chamber into the "safe state" mode.
Patient Sequence No: 1, Text Type: N, H10
[72812510]
On (b)(6) 2016 customer stated that the chamber is not maintaining set pressure. Chamber is also compressing slow. Actual time to 2. 4ata is 25 minutes at rate of 1. 5psi/min. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020676-2017-00005 |
| MDR Report Key | 6491007 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2017-04-13 |
| Date of Report | 2017-03-27 |
| Date of Event | 2016-04-15 |
| Date Mfgr Received | 2017-03-27 |
| Device Manufacturer Date | 2010-02-01 |
| Date Added to Maude | 2017-04-13 |
| 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 Contact | MR. VICTOR ARELLANO |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal | 92807 |
| Manufacturer G1 | SECHRIST INDUSTRIES, INC. |
| Manufacturer Street | 4225 E. LA PALMA AVENUE |
| Manufacturer City | ANAHEIM CA 92807 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92807 |
| 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 | 2017-04-13 |
| Model Number | 3600E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 E. LA PALMA AVENUE ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |