MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-09 for ANESTHETIC VAPORIZER TEC 6 PLUS manufactured by Ge Healthcare / Datex-ohmeda Inc..
[77524536]
High pco2 levels noted during cardiopulmonary bypass by poc blood gas analyzer. Values were rechecked with the same result. Perfusionist started troubleshooting the equipment. The vaporizer was replaced and values returned to normal.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070353 |
| MDR Report Key | 6636313 |
| Date Received | 2017-06-09 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-05-09 |
| Date Added to Maude | 2017-06-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | ANESTHETIC VAPORIZER |
| Generic Name | ANESTHETIC VAPORIZER |
| Product Code | CAD |
| Date Received | 2017-06-09 |
| Model Number | TEC 6 PLUS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE / DATEX-OHMEDA INC. |
| Brand Name | HEART-LUNG MACHINE |
| Generic Name | HEART-LUNG MACHINE |
| Product Code | DTQ |
| Date Received | 2017-06-09 |
| Model Number | S5 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP USA |
| Manufacturer Address | ARVADA CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-09 |