MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2009-04-28 for S/5 ANESTHESIA MONITOR E-CIAO-00 manufactured by Ge Healthcare Finland Oy.
[1205948]
The customer reported that during a case, the physicians on call recognized that they had no gas analysis on the s/5 monitor. This was due to the sample line of the gas analysis module being inadvertently attached to the calibration port. As a result, the physicians were unable to monitor end tidal co2 or oxygen, and were unable to measure the potency of gas delivery. The first issue was well managed as only oxygen was being delivered and the respiratory rate was known. The second issue resulted in the pt receiving twice the amount of anesthetic as intended. While the correct values were displayed on the monitor in the gas settings area, the caregivers did not recognize that sevoflurane was being delivered at 2% because the area that providers are used to referencing (end tidal concentrations) was not functioning. The physicians proceeded with manual ventilation and oxygen. Iv anesthetics were used to keep pt under anesthesia. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2009-00021 |
| MDR Report Key | 1371272 |
| Report Source | 99 |
| Date Received | 2009-04-28 |
| Date of Report | 2009-04-28 |
| Date of Event | 2009-04-09 |
| Date Mfgr Received | 2009-04-09 |
| Device Manufacturer Date | 2008-08-01 |
| Date Added to Maude | 2011-03-21 |
| 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 | ANN LEBAR |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD MAIL CODE - W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482757 |
| 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 ANESTHESIA MONITOR |
| Generic Name | PARAMETER MODULES |
| Product Code | CCL |
| Date Received | 2009-04-28 |
| Model Number | E-CIAO-00 |
| ID Number | E-CAIO |
| 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 | 2009-04-28 |