MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-07 for SECHRIST INDUSTRIES, INC. 3600ER-00 manufactured by Sechrist Industries, Inc..
[66690138]
Patient Sequence No: 1, Text Type: N, H10
[66690139]
No harm to patient. Patient safely removed from chamber. Chamber#1 s/n 360196 not holding pressure at depth of 2. 4 ata/20. 58 psig. No system alarm. Only normal sounds that occur during chamber operation. Notified serena group as soon as discrepency discovered. Manager notified. Emergency call placed to sechrist (b)(4). Sechrist to send service technician. "out of order" sign placed on chamber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6307045 |
| MDR Report Key | 6307045 |
| Date Received | 2017-02-07 |
| Date of Report | 2016-12-28 |
| Date of Event | 2016-02-23 |
| Report Date | 2016-12-28 |
| Date Reported to FDA | 2016-12-28 |
| Date Reported to Mfgr | 2016-12-28 |
| Date Added to Maude | 2017-02-07 |
| 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 |
| 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 INDUSTRIES, INC. |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2017-02-07 |
| Model Number | 3600ER-00 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | 4225 EAST LA PALMA AVE. ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-07 |