MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-17 for SECHRIST AIR/OXYGEN MIXER manufactured by Tenacore Holdings, Inc..
[133354064]
Set screw was not allowing for proper adjustment, restricting the rotating of the dial so the perfusionist was unable to change the fraction of inspired oxygen (fio2) setting as needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8256212 |
| MDR Report Key | 8256212 |
| Date Received | 2019-01-17 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-12-12 |
| Report Date | 2019-01-15 |
| Date Reported to FDA | 2019-01-15 |
| Date Reported to Mfgr | 2019-01-17 |
| Date Added to Maude | 2019-01-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECHRIST AIR/OXYGEN MIXER |
| Generic Name | MIXER, BREATHING GASES, ANESTHESIA INHALATION |
| Product Code | BZR |
| Date Received | 2019-01-17 |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TENACORE HOLDINGS, INC. |
| Manufacturer Address | 1525 E EDINGER AVE SANTA ANA CA 92705 US 92705 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-17 |