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Model Number AW5100-300
Device Problems Inadequate Instructions for Healthcare Professional (1319); Use of Device Problem (1670)
Patient Problems Partial thickness (Second Degree) Burn (2694); Blister (4537)
Event Date 06/17/2021
Event Type  Injury  
Event Description
(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 the blanket. When the patient was moved from the preoperative setting into the operating room, the warming blanket was unplugged. It was reconnected in the surgical room. The crna in charge of this patient was unfamiliar with the blanket and had not received any direction on how the blanket should be used. She attempted to connect the blanket, but was unable to do so correctly. She requested that the encompass rep enter the room to assist, and the encompass did so, plugging in the blanket and turning on the controls. The nova blanket was positioned on the patient's lower body while the patient was lying flat. The top end of the blanket was positioned approximately at the patient's hips, or "hinge point. " the nova warming blanket was over the table safety strap, which was positioned across the patient's upper legs. The patient's nonsurgical left arm was looped into the beach chair strap, which was located across the patient's upper abdomen. When the patient was raised into the "beach chair" position, the patient's lower abdomen and left nonsurgical arm likely rolled down toward the patient's hinge point, and may have rested upon the nova warming blanket. At this point, the "bullseye" sensor on the blanket was positioned at or below the patient's knees, between her legs. On her legs, the nova warming blanket was directly on the patient's skin. At her abdomen, in the area where the burns appeared, the patient's gown was under the nova warming blanket. Other than the surgical sterile drape, there was no object or material over the blanket, except to the extent that her abdomen and left nonsurgical arm rested on the top portion of the blanket. When the surgery was completed, the patient was lowered from the "beach chair" position to lying flat. Her surgical arm was secured. The nova warming blanket was disconnected, and the patient was moved from the surgical table to a gurney and transported to the post anesthesia care unit (pacu). The nova warming blanket remained on her to provide passive warmth. The warming blanket was not plugged in for active use in the pacu. After the patient arrived in the pacu, a pacu nurse discovered the blisters across the patient's lower abdomen. Manufacturer had not provided or instructed, any indication for required testing for device usage. Fda safety report id # (b)(4).
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Manufacturer (Section D)
mcdonough GA 30253
MDR Report Key12313480
MDR Text Key266877170
Report NumberMW5103205
Device Sequence Number1
Product Code DWJ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberAW5100-300
Device Lot Number1971322
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 08/11/2021 Patient Sequence Number: 1