MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-04-08 for SECHRIST HYPERBARIC VENTILATOR 500A manufactured by Sechrist.
[1870978]
Pt in hyperbaric chamber on ventilator with direct observation via resp therapist/critical care nurse and hyperbaric rn. Pt completed 1 hr and 30 minutes of 1 hr 50 minute treatment when ventilator stopped working. There was no oxygen cycling the ventilator. Treatment was stopped and pt removed from chamber and ventilated with bvm. Oxygen sats remained over 90% and to 100% with bvm and oxygen. Pt returned to unit with full exam by (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020232 |
| MDR Report Key | 2057581 |
| Date Received | 2011-04-08 |
| Date of Report | 2011-04-08 |
| Date of Event | 2011-04-07 |
| Date Added to Maude | 2011-04-19 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECHRIST HYPERBARIC VENTILATOR |
| Generic Name | HYPERBARIC VENTILATOR |
| Product Code | CBF |
| Date Received | 2011-04-08 |
| Model Number | 500A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SECHRIST |
| Manufacturer Address | 4225 E. LA PALMA AVE. ANAHEIM CA 92807 US 92807 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-04-08 |