MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2014-03-11 for E-CAIOV S/5 COMPACT AIRWAY MODULE manufactured by Ge Healthcare Finland Oy.
[18298366]
This record reports a ge healthcare module was being used during a dental procedure in which the pt coded and subsequently expired. The physician reports there is a difference in the percentage of anesthesia agent he dials in and the percentage computed by the module.
Patient Sequence No: 1, Text Type: D, B5
[18664864]
Pt weight: pt weight was not provided. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00002 |
| MDR Report Key | 3687387 |
| Report Source | 00,01 |
| Date Received | 2014-03-11 |
| Date of Report | 2014-02-04 |
| Date of Event | 2014-01-31 |
| Date Mfgr Received | 2014-02-13 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2014-03-20 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HEALTHCARE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-CAIOV S/5 COMPACT AIRWAY MODULE |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2014-03-11 |
| 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. Death | 2014-03-11 |