MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2010-07-30 for CARDIOCAP 5 manufactured by Ge Healthcare Finland.
[1631721]
A customer reported that at approx 8 pm, one ecg electrode was disconnected from a pt when they became restless. The cardiocap 5 allegedly did not activate an alarm. The pt reportedly expired. Following the event, a ge field engineer tested the monitor in question with an ecg simulator and was found to function correctly. Ge healthcare's investigation into the reported occurrence is still ongoing. A f/u report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2010-00012 |
| MDR Report Key | 1783766 |
| Report Source | 01,06 |
| Date Received | 2010-07-30 |
| Date of Report | 2010-07-30 |
| Date of Event | 2010-06-29 |
| Date Mfgr Received | 2010-07-02 |
| Device Manufacturer Date | 2003-07-01 |
| Date Added to Maude | 2010-08-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBRA LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY. |
| Manufacturer City | BARRINGTON IL 600103076 |
| Manufacturer Country | US |
| Manufacturer Postal | 600103076 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE FINLAND |
| Manufacturer City | OY, HELSINKI |
| Manufacturer Country | FI |
| 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 | 2010-07-30 |
| 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 |
| Manufacturer Address | OY, HELSINKI FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2010-07-30 |