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 2017-06-22 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[78174604]
Ge healthcare? S investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[78174605]
The hospital reported higher than expected carbon dioxide readings. It was subsequently reported that the patient suffered neuro deficits and was transferred to a long term care facility.
Patient Sequence No: 1, Text Type: D, B5
[106759757]
Gehc service representatives performed a checkout of the equipment. During the testing, no leaks were present when the tec 6 plus vaporizer was mounted properly on the cardiopulmonary anesthesia vaporizer bracket. A leak was observed when force was applied to the mounted vaporizer. Inspection of the equipment noted the bracket had worn/flattened o-rings and a deformed dzus spring. The root cause of the alleged event was determined to be a leak of the fresh gas between the tec 6 plus vaporizer and the cardiopulmonary anesthesia vaporizer bracket due to worn/flattened o-rings and a deformed dzus spring. Both of these items are part of the annual maintenance, as indicated in the user? S reference manual. The hospital confirmed they are not performing the maintenance on the bracket (manufactured in 1996) as outlined in the manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2112667-2017-01149 |
| MDR Report Key | 6660083 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-22 |
| Date of Report | 2017-09-13 |
| Date of Event | 2017-05-02 |
| Date Mfgr Received | 2017-08-17 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-06-22 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JOHN SZALINSKI |
| Manufacturer Street | 540 W. NORTHWEST HIGHWAY |
| Manufacturer City | BARRINGTON IL |
| 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 | 2017-06-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2017-06-22 |