MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-06-16 for S/5 COMPACT AIRWAY MODULE E-CAIO manufactured by Ge Healthcare Finland Oy.
[2030904]
It was reported by the hospital that "the pt has partial recall of their surgery". At some point (exact details unavailable) the e-caio module used during the surgery was tested against a simulator and the oxygen (o2) was not calibrating correctly. Ge healthcare's investigation is ongoing. A f/u report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2011-00017 |
| MDR Report Key | 2133612 |
| Report Source | 05,06 |
| Date Received | 2011-06-16 |
| Date of Report | 2011-06-16 |
| Date of Event | 2011-05-18 |
| Date Mfgr Received | 2011-05-18 |
| Date Added to Maude | 2011-06-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| 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 | S/5 COMPACT AIRWAY MODULE E-CAIO |
| Generic Name | OXYGEN GAS ANALYZER |
| Product Code | CCL |
| Date Received | 2011-06-16 |
| 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 | 2011-06-16 |