CADD Adverse Event — Malfunction (MDR 3012307300-2020-03459)
CADD Adverse Event — Malfunction (MDR 3012307300-2020-03459) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CADD; Manufacturer: ST PAUL; Report number: 3012307300-2020-03459.
| Device | CADD |
|---|---|
| Manufacturer | ST PAUL |
| Report number | 3012307300-2020-03459 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | EVALUATION RESULTS: ONE CADD MS3 PUMP WAS RETURNED FOR INVESTIGATION IN GOOD CONDITION. THERE WAS NO EVIDENCE OF THE REPORTED PRODUCT PROBLEM (PUMP RUNNING TOO FAST) IN THE EVENT HISTORY LOG. FUNCTIONAL TESTING WAS PERFORMED. THE INVESTIGATOR WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM.THE PUMP SUCCESSFULLY PASSED ALL THE FUNCTIONAL TESTS. THE PUMP RAN THE PROGRAM FOR AN EXTENDED PERIOD OF TIME W |
| Source | openFDA MAUDE (device adverse events) |
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