MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-02-23 for TEC 6 PLUS manufactured by Datex-ohmeda, Inc..
[39303897]
Ge is awaiting the return of the malfunctioning vaporizer before beginning an evaluation. A follow-up report will be submitted upon completion of the evaluation. No report of patient involvement. Device evaluation anticipated, but not yet begun.
Patient Sequence No: 1, Text Type: N, H10
[39303898]
Third party service organization reported that, during routine maintenance, it was noted that the unit's interlock system was not functioning. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
[43555009]
The unit was returned to the manufacturing site for investigation. The unit was tested and the reported complaint was confirmed. During inspection of the unit, it was noted that the interlock plunger pin circlip was missing. The circlip was replaced, resolving the reported complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2112667-2016-00336 |
| MDR Report Key | 5454022 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-02-23 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-01-25 |
| Date Mfgr Received | 2016-04-14 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2016-02-23 |
| 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 | BRAD WHEELER |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD., W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| 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 | 2016-02-23 |
| 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 DRIVE MADISON WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-23 |