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 2017-02-13 for TEC 7 manufactured by Datex-ohmeda, Inc..
[67294807]
(b)(6). A ge healthcare service representative performed a checkout of the equipment. The unit failed leak and output testing. The unit was sent to the manufacturing site for investigation. The unit was tested and found to fail leak testing due to the quad seal. Site correction can't be confirmed because it is the responsibility of another vendor.
Patient Sequence No: 1, Text Type: N, H10
[67294808]
The hospital reported that following the case, the patient reported having recall of the surgical procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2112667-2017-00301 |
| MDR Report Key | 6327317 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-13 |
| Date of Report | 2017-02-13 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2009-06-04 |
| Date Added to Maude | 2017-02-13 |
| 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 | 2017-02-13 |
| 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 DRIVE MADISON WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |