MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03442)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03442) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDFUSION; Generic name: PUMP, INFUSION; Manufacturer: ST PAUL.
| Device | MEDFUSION |
|---|---|
| Generic name | PUMP, INFUSION |
| Manufacturer | ST PAUL |
| Report number | 3012307300-2020-03442 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | EVALUATION RESULTS: ONE MEDFUSION WAS RETURNED FOR INVESTIGATION IN USED CONDITION. THE TAMPER SEAL WAS MISSING AND THE TOP CASE WAS CRACKED FROM THE HANDLE. THE INVESTIGATOR WAS UNABLE TO GET INTO ALARM HISTORY BECAUSE THE PUMP WOULD NOT POWER ON PROPERLY. THE INVESTIGATOR OBSERVED A BLANK SCREEN AND A CONSTANT ALARM DURING START UP. THIS ISSUE WAS RESOLVED AFTER THE INVESTIGATOR REPLACED THE MAI |
| Source | openFDA MAUDE (device adverse events) |
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