MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2007-02-06 for VALVE, PRESSURE RELIEF IV-317K IV317K manufactured by Sechrist Industries, Inc..
[573402]
Adjustment spindle unwound during hbo treatment reportedly due to pt coughing. Treatment in hbo chamber continued as pt was breathing spontaneously. No pt injury compromise.
Patient Sequence No: 1, Text Type: D, B5
[7942263]
Unable to verify customer's complaint that spindle of pressure relief valve unwoud during use. No problem could be found, visually or mechanically. It appears to be user error. User advised by field rep to read and follow instructons for use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2020676-2007-00002 |
| MDR Report Key | 827461 |
| Report Source | 01,08 |
| Date Received | 2007-02-06 |
| Date of Report | 2007-02-06 |
| Date of Event | 2006-10-30 |
| Date Facility Aware | 2006-11-08 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2007-03-15 |
| 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 | GREG GODFREY |
| Manufacturer Street | 4225 E 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 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 | VALVE, PRESSURE RELIEF |
| Generic Name | * |
| Product Code | CBP |
| Date Received | 2007-02-06 |
| Model Number | IV-317K |
| Catalog Number | IV317K |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 814858 |
| Manufacturer | SECHRIST INDUSTRIES, INC. |
| Manufacturer Address | * ANAHEIM CA * US |
| Baseline Brand Name | VALVE/PRESSURE RELIEF |
| Baseline Generic Name | * |
| Baseline Model No | IV-317K |
| Baseline Catalog No | IV317K |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-02-06 |