MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-05-22 for E-CAIO manufactured by Ge Healthcare Finland Oy.
[16597571]
This customer reports that the e-caio gas module provided inaccurately high fico2 and etco2 readings during a procedure. The patient was manually bagged with an ambu bag and medicated with propofol. No further consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[16691094]
Patient data not currently available. Email address of reporter unknown. Date of manufacture unknown at this time. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00012 |
| MDR Report Key | 3850600 |
| Report Source | 05,06 |
| Date Received | 2014-05-22 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-04-23 |
| Date Mfgr Received | 2014-04-23 |
| Date Added to Maude | 2014-06-06 |
| 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 | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY. |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-CAIO |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2014-05-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2014-05-22 |