ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02896)
ARCTIC SUN 5000 Adverse Event — Malfunction (MDR 1018233-2020-02896) 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 | 1018233-2020-02896 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, OTHER |
| Narrative | IT WAS REPORTED THAT THERE WAS A CIRCUIT FAILURE. THERE WAS AN ALARM 76. MS&S ASKED THE NURSE TO CYCLE THE POWER. MS&S SUGGESTED IF THE ALARM DOES NOT RETURN, THEY MAY CONTINUE THERAPY. IF THE ALARM RETURNS, SEND THE DEVICE TO BIOMED AND CHANGE TO A 2ND DEVICE IF AVAILABLE. PER FOLLOW UP ON 9APR2020, NURSE (B)(6) STATED THEY WOULD HAVE A LOCAL REPRESENTATIVE TO COME LOOK AT THE DEVICE. THE DEVICE |
| Source | openFDA MAUDE (device adverse events) |
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