CARDIOMEMS PATIENT ELECTRONIC SYSTEM Adverse Event — Malfunction (MDR 3004936110-2020-00198)
CARDIOMEMS PATIENT ELECTRONIC SYSTEM Adverse Event — Malfunction (MDR 3004936110-2020-00198) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CARDIOMEMS PATIENT ELECTRONIC SYSTEM; Generic name: SYSTEM, HEMODYNAMIC, IMPLANTABLE; Manufacturer: ST. JUDE MEDICAL, INC..
| Device | CARDIOMEMS PATIENT ELECTRONIC SYSTEM |
|---|---|
| Generic name | SYSTEM, HEMODYNAMIC, IMPLANTABLE |
| Manufacturer | ST. JUDE MEDICAL, INC. |
| Report number | 3004936110-2020-00198 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, CONSUM |
| Narrative | DURING DEVICE ANALYSIS, THE REPORTED ERROR WAS TRACED TO AN INCORRECT SPEED SETTING OF THE COMPACT FLASH. |
| Source | openFDA MAUDE (device adverse events) |
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