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 2017-03-31 for TEC 7 manufactured by Datex-ohmeda, Inc..
[71387211]
No report of patient involvement. The date of manufacture was not available at the time of filing. The hospital reported the unit will be returned to a third party service organization for replacement. The unit will not be returned to ge healthcare for investigation. An exact root cause determination for the reported complaint cannot be determined without the no report of patient involvement. The date of manufacture was not available at the time of filing.
Patient Sequence No: 1, Text Type: N, H10
[71387212]
The hospital reported the unit failed the preoperative leak test. There was no report of patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2017-00606 |
| MDR Report Key | 6449632 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-31 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-03-06 |
| Device Manufacturer Date | 1970-01-01 |
| Date Added to Maude | 2017-03-31 |
| 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 | 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 | 2017-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DRIVE MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-31 |