ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02889)
ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02889) 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 | 1018233-2020-02889 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, OTHER |
| Narrative | IT WAS REPORTED THAT THE PATIENT WAS NOT COOLING ON THE ARCTIC SUN DEVICE. THE PATIENT WAS AT 37.3C AND THE TARGET WAS 33C. THE DEVICE WAS TURNED OFF. THE EVENT LOG SHOWED MULTIPLE ALERT 113. MS&S EXPLAINED THE ALERT/ THE NURSE DECLINED TO TROUBLE SHOOT BECAUSE SHE WAS GOING TO GET ANOTHER DEVICE AND SEND THE DEVICE TO BIOMED. |
| Source | openFDA MAUDE (device adverse events) |
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