MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2009-11-13 for AS/3 AIRWAY MODULE G-AIO-00-04 manufactured by Ge Healthcare Finland Oy.
[1118620]
It was reported that a patient awoke during an operation, and pulled the endotracheal tube from her mouth when the instrument was inserted into the muscle wall. The patient reportedly sustained no injuries and has no recollection of the event. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2009-00034 |
| MDR Report Key | 1531097 |
| Report Source | 01,05,06 |
| Date Received | 2009-11-13 |
| Date of Report | 2009-11-13 |
| Date of Event | 2009-10-22 |
| Date Mfgr Received | 2009-10-22 |
| Date Added to Maude | 2009-11-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANN LEBAR |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. MAIL CODE - W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482757 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer City | HELSINKI |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AS/3 AIRWAY MODULE |
| Generic Name | HALOTHANE GAS ANALYZER |
| Product Code | CBS |
| Date Received | 2009-11-13 |
| Model Number | G-AIO-00-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-11-13 |