MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2009-07-15 for CARDIOCAP 5 6051-0000-164/ M00 manufactured by Ge Healthcare Finland Oy.
[17468850]
A customer reported that the cc5 monitor shut off while monitoring a patient. The user was unable to reboot the monitor. A replacement monitor was put into use approximately 5 minutes later. No patient injury was reported. 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
[17682630]
Device manufacture date unknown. Device shipped 12/2008.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2009-00028 |
| MDR Report Key | 1480227 |
| Report Source | 07 |
| Date Received | 2009-07-15 |
| Date of Report | 2009-07-15 |
| Date of Event | 2009-06-25 |
| Date Mfgr Received | 2009-06-25 |
| Date Added to Maude | 2010-08-02 |
| 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 | CARDIOCAP 5 |
| Generic Name | CONFIGURED MONITORS |
| Product Code | MLD |
| Date Received | 2009-07-15 |
| Model Number | 6051-0000-164/ M00 |
| 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 | 2009-07-15 |