Novii 107-PT-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060433670060), received between Nov 17, 2016 and Nov 17, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fire” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2016Fire; Fire

  ON (B)(6). MONICA WAS INFORMED THERE HAD BEEN AN INCIDENT WITH A NOVII POD AT THE (B)(6) HOSPITAL IN (B)(6) WHERE A POD OVERHEATED WHILST ON CHARGE AND BEGAN EMITTING SPARKS BEFORE MELTING THE EXTERIOR POD PLASTIC. NO-ONE WAS HURT. THE POD WAS ON CHARGE IN A STOCKROOM AT THE TIME AND A JUNIOR NURSE WAS PRESENT AND HEARD A POP, FOLLOWED BY SPARKS AND SMOKE. THE L&D MANAGER DOUSED THE NOVII SYSTEM WITH A POWDER FIRE EXTINGUISHER AND THE HOSPITAL FIRE DEPARTMENT WAS CALLED. MONICA'S CLINICAL SPECIALIST, (B)(6), HAPPENED TO BE AT THE HOSPITAL AT THE TIME. THE IMMEDIATE HYPOTHESIS WAS THAT THE LITHIUM-POLYMER BATTERY WITHIN THE NOVII POD COULD BE THE CAUSE AND THE FACT THAT THE FAILURE OCCURRED DURING CHARGING, I.E. AT A TIME WHEN THE BATTERY CHEMISTRY IS MOST VOLATILE, APPEARED TO SUPPORT THIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6110917 ↗