MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-11-26 for COMPACT AIRWAY MODULE E-CAIO * manufactured by Ge Healthcare.
[1801717]
After intubation of patient, the "gas vapor analyzer" malfunctioned and there was a 14 minute delay in switching it out for a new machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1913239 |
| MDR Report Key | 1913239 |
| Date Received | 2010-11-26 |
| Date of Report | 2010-11-26 |
| Date of Event | 2010-07-06 |
| Report Date | 2010-11-26 |
| Date Reported to FDA | 2010-11-26 |
| Date Added to Maude | 2010-12-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT AIRWAY MODULE |
| Generic Name | GAS MONITORING AND METABOLICS MODULE |
| Product Code | CCL |
| Date Received | 2010-11-26 |
| Model Number | E-CAIO |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE |
| Manufacturer Address | 3000 N. GRANDVIEW BLVD MAILSTOP: W450 WAUKESHA WI 53188 US 53188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-11-26 |