MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03443)
MEDFUSION Adverse Event — Malfunction (MDR 3012307300-2020-03443) 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 | 3012307300-2020-03443 |
| 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. BOTH TAMPER SEALS WERE REMOVED. THE TOP AND BOTTOM CASES WERE IN EXCELLENT CONDITION DESPITE SOME VISIBLE CONTAMINATION. NOTHING WAS FOUND IN THE EVENT HISTORY LOG (EHL) WHICH PERTAINED TO A BAD INTERCONNECT BOARD. THE CUSTOMER REPORTED PRODUCT PROBLEM REGARDING THE BAD INTERCONNECT BOARD WAS CONFIRMED. THE CUSTOME |
| Source | openFDA MAUDE (device adverse events) |
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