CADD Adverse Event — Malfunction (MDR 3012307300-2020-03404)
CADD Adverse Event — Malfunction (MDR 3012307300-2020-03404) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: CADD; Generic name: SOLIS, VIP; Manufacturer: SMITHS MEDICAL ASD, INC..
| Device | CADD |
|---|---|
| Generic name | SOLIS, VIP |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Report number | 3012307300-2020-03404 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | USER FACILITY |
| Narrative | DEVICE EVALUATION: ONE SMITHS MEDICAL CADD SOLIS VIP PUMP WAS RETURNED FOR ANALYSIS. DURING ANALYSIS, THE REPORTED EVENT WAS ABLE TO BE DUPLICATED. SERVICE TRIMMED THE EXPULSOR TO BRING DELIVERY TO A MORE NOMINAL RANGE TO CORRECT THE REPORTED ISSUE. SERVICE ALSO LOADED SOFTWARE AND CALIBRATED THE DEVICE. BASED ON THE EVIDENCE, THE COMPLAINT WAS CONFIRMED, AND THE PROBLEM SOURCE OF THE REPORTED EVE |
| Source | openFDA MAUDE (device adverse events) |
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