MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2015-01-13 for E-CAIOV manufactured by Ge Healthcare Finland Oy.
[5372670]
The customer reports that during a cholecystectomy a carescape b650 in conjunction with the e-caiov gas module did not provide co2 readings nor did it alarm. The patient did not survive the event.
Patient Sequence No: 1, Text Type: D, B5
[12757786]
Ge healthcare's investigation is ongoing. A follow-up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10
[12833654]
Root cause undetermined. Gas module (e-caiov), and b650 monitor were checked by gehc field engineer and found to function within manufacturing specifications. Gas module was used for one spinal case and monitor with two more cases that day with no further reported complaints. The investigation concludes the device was operating to specification and did not malfunction.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2015-00002 |
| MDR Report Key | 4414112 |
| Report Source | 01 |
| Date Received | 2015-01-13 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-04 |
| Date Mfgr Received | 2015-02-06 |
| Date Added to Maude | 2015-01-13 |
| 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 | RADIOLOGIC TECHNOLOGIST |
| 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 FINLAND OY |
| Manufacturer Street | KUORTANEENKATU 2 |
| Manufacturer City | HELSINKI, 510 |
| Manufacturer Country | FI |
| Manufacturer Postal Code | 510 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-CAIOV |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2015-01-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | KUORTANEENKATU 2 HELSINKI, FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-01-13 |