ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02866)
ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02866) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ARCTIC SUN 5000; Generic name: ARCTIC SUN DEVICE; Manufacturer: MEDIVANCE, INC. ¿ 1725056.
| Device | ARCTIC SUN 5000 |
|---|---|
| Generic name | ARCTIC SUN DEVICE |
| Manufacturer | MEDIVANCE, INC. ¿ 1725056 |
| Report number | 1018233-2020-02866 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, OTHER |
| Narrative | THE REPORTED ISSUE WAS INCONCLUSIVE. THE ROOT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THE REPORTED ISSUE COULD BE A FAULTY MIXING PUMP. HOWEVER, THIS CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE W |
| Source | openFDA MAUDE (device adverse events) |
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