Nova AW5100-300Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00612899006492), received between Jul 23, 2021 and Aug 11, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Inadequate Instructions for Healthcare Professional; Use of Device Problem

  (B)(6) HOSPITAL - PRODUCT EVALUATION OF THE NOVA PATIENT WARMING SYSTEM ON (B)(6) 2021; INFORMATION COLLECTED FROM HOSPITAL STAFF WHO USED THE NOVA PATIENT WARMING SYSTEM: THIRTEEN SURGICAL PATIENTS WERE INCLUDED IN THE PILOT PROGRAM. OF THOSE THIRTEEN, TWELVE PATIENTS UNDERWENT SURGERY WHILE IN A PRONE OR SUPINE POSITION. NONE OF THOSE TWELVE PATIENTS SUFFERED ADVERSE CONSEQUENCES FROM THE USE OF THE NOVA BLANKET. ONE PATIENT UNDERWENT SURGERY IN THE "BEACH CHAIR" POSITION AND IT IS THIS PATIENT WHO SUFFERED BURNS TO HER LOWER ABDOMEN. THE PATIENT WHO UNDERWENT SURGERY IN THE "BEACH CHAIR" POSITION WAS A TOTAL SHOULDER REPLACEMENT. SHE HAD HER RIGHT SHOULDER REPLACED. FROM THE OUTSET, SHE WAS ON THE SCHEDULE OF PATIENTS FOR THE PILOT PROGRAM. THE ONLY CHANGE REGARDING THIS PATIENT IS THAT THE PLANNED SURGICAL ROOM WAS CHANGED WHEN ANOTHER SURGERY CANCELLED. THIS CHANGE OCCURRED ON (B)(6). HER SURGERY WAS SCHEDULED FOR (B)(6), AND THAT SCHEDULE DID NOT CHANGE. FOR THIS PATIENT, THE WARMING BLANKET WAS PLACED ON HER IN THE PREOPERATIVE SETTING, BY THE ENCOMPASS REPRESENTATIVE. (B)(6) STAFF WERE PRESENT AND OBSERVED THE PROCESS, BUT WERE NOT DIRECTLY INVOLVED IN THE APPLICATION OF TH

  Patient problems: Blister; Partial thickness (Second Degree) Burn

  MAUDE report 12313480 ↗
• InjuryJul 23, 2021Insufficient Device Problem Information

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 12216778 ↗