MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-06-28 for TEC 7 manufactured by Datex-ohmeda, Inc..
[78609601]
(b)(6). A ge healthcare service representative performed a checkout of the equipment. The vaporizer was found to fail leak testing. According to the hospital, the vaporizer has been sent to a third party service organization.
Patient Sequence No: 1, Text Type: N, H10
[78609602]
Per user filed medwatch report, mw5070188: "crna smelled anesthesia gases and thought it was the pt's airway but could not find a leak. She became dizzy, and asked for another clinician to come into the room. The isoflurane vaporizer was leaking. Vaporizer turned off. Anesthesia tech removed the vaporizer and placed a new one on the machine. After several minutes, the second vaporizer was noted to be leaking. Second clinician took over the case, first clinician put on oxygen by nasal canula and called employee health, treated in the emergency room. Machine, vaporizers, and patient circuit removed and sent to biomed. Another machine was placed on patient. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2017-01195 |
| MDR Report Key | 6674167 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-28 |
| Date of Report | 2017-06-28 |
| Date of Event | 2017-04-28 |
| Date Mfgr Received | 2017-06-05 |
| Device Manufacturer Date | 2015-12-16 |
| Date Added to Maude | 2017-06-28 |
| 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 | JOSEPH SELIGA |
| Manufacturer Street | 3000 N GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEC 7 |
| Generic Name | VAPORIZER |
| Product Code | CAD |
| Date Received | 2017-06-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DR, MADISON, WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-28 |