MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-06 for HYPERBARIC OXYGEN CHAMBER manufactured by Sechrist Industries, Inc..
[56566335]
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Patient Sequence No: 1, Text Type: N, H10
[56566336]
No harm to patient. Treatment was complete when system error "e301" and alarm occurred. Patient safely removed from chamber and transported on the gurney to an adjoining room. Notified the national safety director of an acute and chronic wound care organization. Discussed events with service technician for the manufacturer. Chamber run through five cycles at varying depths and rates as advised by the manufacturer without duplication of error. Chamber not removed from unit, however, signage was placed on machine to remove from service until inspected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6002532 |
| MDR Report Key | 6002532 |
| Date Received | 2016-10-06 |
| Date of Report | 2016-09-22 |
| Date of Event | 2015-12-04 |
| Report Date | 2016-09-22 |
| Date Reported to FDA | 2016-09-22 |
| Date Reported to Mfgr | 2016-09-22 |
| Date Added to Maude | 2016-10-06 |
| 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 | HYPERBARIC OXYGEN CHAMBER |
| Generic Name | CHAMBER, HYPERBARIC |
| Product Code | CBF |
| Date Received | 2016-10-06 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-10-06 |