ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02857)
ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02857) 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 | 1018233-2020-02857 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| 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 CIRCULATION 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 |
| Source | openFDA MAUDE (device adverse events) |
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