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 2016-03-10 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[40085604]
No report of patient involvement. The unit was returned to the manufacturing site for investigation. The unit was tested, and the reported complaint was confirmed. It was further noted that the c-clip was missing from the pivot pin. A plunger, pivot pin, and c-clip were installed to correct the issue.
Patient Sequence No: 1, Text Type: N, H10
[40085685]
The hospital reported that, during routine maintenance testing, the interlock system was not functioning. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2016-00455 |
| MDR Report Key | 5492682 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-03-10 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-02-12 |
| Date Mfgr Received | 2016-02-12 |
| Device Manufacturer Date | 2008-03-06 |
| Date Added to Maude | 2016-03-10 |
| 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 | STEPHANIE CASS |
| Manufacturer Street | 3000 N. GRANDVIEW BOULEVARD |
| Manufacturer City | WAUKESHA WI 531881696 |
| Manufacturer Country | US |
| Manufacturer Postal | 531881696 |
| Manufacturer G1 | DATEX-OHMEDA, INC. |
| Manufacturer Street | 3030 OHMEDA DRIVE |
| Manufacturer City | MADISON WI 53718 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53718 |
| 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 | 2016-03-10 |
| Returned To Mfg | 2016-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-10 |