MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03424)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03424) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: MEDFUSION; Generic name: PUMP, INFUSION; Manufacturer: SMITHS MEDICAL ASD, INC..
| Device | MEDFUSION |
|---|---|
| Generic name | PUMP, INFUSION |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Report number | 3012307300-2020-03424 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | CONSUMER |
| Narrative | ONE MEDFUSION PUMP WAS RECEIVED WITH THE TOP CASE CRACKED AND CHIPPED. THE BOTTOM CASE HAD SEAL DAMAGE. THE EVENT HISTORY LOG WAS REVIEWED AND THERE WAS A CONFIGURATION ERROR AT START-UP. SOME OF THE KEYS ON THE KEYPAD DID NOT WORK. A START-UP TEST WAS CONDUCTED AND THE REPORTED ISSUE WAS ABLE TO BE REPLICATED. THE PUMP NEEDED TO BE UPLOADED FROM THE BOTTOM CASE. THE ISSUE WAS USER INDUCED AS THE |
| Source | openFDA MAUDE (device adverse events) |
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