MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-01 for HEMODYNAMIC MONITORING manufactured by Camtronics/ Merge Healthcare.
[6018490]
During emergent heart cath procedure camtronica hemodynamic monitoring system went down. Operator described as the data display freezing up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5043698 |
| MDR Report Key | 4898968 |
| Date Received | 2015-07-01 |
| Date of Report | 2015-07-01 |
| Date of Event | 2015-05-23 |
| Date Added to Maude | 2015-07-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMODYNAMIC MONITORING |
| Generic Name | HEMODYNAMIC MONITORING |
| Product Code | ONA |
| Date Received | 2015-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAMTRONICS/ MERGE HEALTHCARE |
| Manufacturer Address | WI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-01 |