MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-12-23 for CARDIOCAP 5 manufactured by Ge Healthcare Finland Oy.
[17874070]
It was reported that there were no audible tones for ecg or spo2. The clinician reported performed a factory reset on the monitor, and the issue was still present. It is unk whether the device was in use with a pt at the time. No injury was reported. Ge healthcare's investigation into the reported occurrence is ongoing. A f/u report will be submitted when the investigation results are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610105-2011-00029 |
| MDR Report Key | 2422942 |
| Report Source | 06 |
| Date Received | 2011-12-23 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-12-02 |
| Date Mfgr Received | 2011-12-02 |
| Device Manufacturer Date | 2001-12-01 |
| Date Added to Maude | 2012-05-04 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| 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 | CARDIOCAP 5 |
| Generic Name | PATIENT MONITOR |
| Product Code | MLD |
| Date Received | 2011-12-23 |
| 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 | 2011-12-23 |