MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2010-06-16 for CARDIOCAP 5 manufactured by Ge Healthcare Finland.
[1623278]
It was reported that during a case, the anesthetist left the operating room for a period of time. Upon his return, he reportedly noticed that the cardiocap 5 monitor did not show sp02 or nip data. No alarm was reportedly heard; the monitor screen showed 2 "little stripes". The anesthetist reportedly checked the monitor cables, with no result. It was subsequently noted that the anesthesia system was not functioning in mechanical mode. The anesthetist reportedly switched to manual mode to maintain ventilation. The patient expired. 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 | 9610105-2010-00011 |
| MDR Report Key | 1728349 |
| Report Source | 01,05,06 |
| Date Received | 2010-06-16 |
| Date of Report | 2010-06-16 |
| Date of Event | 2010-05-19 |
| Date Mfgr Received | 2010-05-20 |
| Date Added to Maude | 2010-06-22 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | DEBRA LAHR |
| Manufacturer Street | 540 W NORTHWEST HIGHWAY |
| Manufacturer City | BARRINGTON IL 600103076 |
| Manufacturer Country | US |
| Manufacturer Postal | 600103076 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE |
| Manufacturer Street | * |
| Manufacturer City | MILWAUKEE WI * |
| Manufacturer Country | US |
| Manufacturer Postal Code | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOCAP 5 |
| Generic Name | CONFIGURED MONITORS |
| Product Code | MLD |
| Date Received | 2010-06-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND |
| Manufacturer Address | OY, HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-06-16 |