MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2013-02-01 for HYPERBARIC VENTILATOR 500A 3000 manufactured by Sechrist Industries, Inc..
[18526332]
A biomedical technician for the hospital reported that during a scheduled performance maintenance test it was found that the ventilator presure did not compensate for the chamber pressure.
Patient Sequence No: 1, Text Type: D, B5
[18756475]
The reported failure was verified and duplicated. Evaluation of the device took place by the manufacturer. The exhalation knob turns past the stop due to the knob being set at the incorrect height. This allowed the knob to slip past the stop pin. Further testing found that the maximum inhalation and exhalation times and the minimum inhalation time were out of specification. The tidal volume at 1000 is out of specification at 2. 0ata, 2. 5ata and 3. 0ata. The immediate cause of the inhalation and exhalation times and tidal volume being out of specification was a malfunctioning fluidic interface.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2013-00001 |
| MDR Report Key | 2971114 |
| Report Source | 00,06 |
| Date Received | 2013-02-01 |
| Date of Report | 2013-02-01 |
| Date of Event | 2013-01-04 |
| Date Mfgr Received | 2013-01-04 |
| Device Manufacturer Date | 1978-06-08 |
| Date Added to Maude | 2013-04-18 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 4225 EAST 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 EAST LA PALMA AVE. |
| 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 VENTILATOR |
| Generic Name | VENTILATOR, CONTINUOUS, FACILITY USE |
| Product Code | CBF |
| Date Received | 2013-02-01 |
| Model Number | 500A |
| Catalog Number | 3000 |
| Operator | OTHER |
| 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 | 2013-02-01 |