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 2018-10-01 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[122308235]
A ge healthcare (gehc) service representative performed a checkout of the equipment. It was reported to gehc that the vaporizer was plugged into the wall and not the anesthesia machine. When the anesthesia machine was moved, the vaporizer unknowingly became unplugged from the wall. It is unknown when the vaporizer became unplugged. During the reported case, the vaporizer was able to be turned on without being powered on. The vaporizer was replaced. The customer contact reported there was no further patient information available.
Patient Sequence No: 1, Text Type: N, H10
[122308236]
The hospital reported that the patient's blood pressure and heart rate were noted to be higher than expected. The clinician switched to another anesthetic agent. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2112667-2018-01916 |
MDR Report Key | 7923242 |
Report Source | HEALTH PROFESSIONAL,USER FACI |
Date Received | 2018-10-01 |
Date of Report | 2018-10-01 |
Date of Event | 2018-08-21 |
Date Mfgr Received | 2018-09-04 |
Device Manufacturer Date | 2013-10-06 |
Date Added to Maude | 2018-10-01 |
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 |
Reporter Occupation | BIOMEDICAL ENGINEER |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Manufacturer Contact | JOHN SZALINSKI |
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 6 PLUS |
Generic Name | VAPORIZER |
Product Code | CAD |
Date Received | 2018-10-01 |
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 53718 US 53718 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2018-10-01 |