MAUDE Adverse Event Report: THE SURGICAL COMPANY INTERNATIONAL BV MISTRAL AIR WARMING UNIT; SYSTEM, THERMAL REGULATING

Model Number MA1100-PM

Device Problem Electrical Shorting (2926)

Patient Problem Burn(s) (1757)

Event Date 03/12/2019

Event Type  malfunction  

Event Description

During a surgical case, a stryker mistral air unit was in use warming the patient.The mistral air reflective drape was on the patient, under the surgical drapes.A portion of the mistral air reflective drape was hanging over and touching the mistral air unit.When the electrosurgical pencil was deployed at the field, the mistral air unit would alarm.Biomed was brought to the room to investigate and when the mistral air unit was pulled out and the mistral reflective drape no longer was touching the unit the alarm ceased.At the end of the case, the biomed set up the same blanket on an empty or bed to investigate if there were any electrical issues with the electrosurgical unit (esu) or the mistral unit.He could not identify any biomedical issues with either device.However, he was able to produce the following serious issue: the mistral reflective drape was placed on an empty or bed, with the unit on and warm air circulating through the device.He placed a grounding pad for the esu on himself and plugged in a esu pencil and turned the esu on.He deployed the pencil into the air (he was attempting to see if the unit would alarm) while doing this he touched the reflective coating on the mistral reflective drape and his finger was immediately burned as if cauterized.The esu pencil was not in contact with his body at all, just deployed into the air.We changed out the esu, the esu pencil, the esu grounding pad, the mistral air unit and the mistral air reflective drape and the burn was reproducible every time.

• Brand Name: MISTRAL AIR WARMING UNIT
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): THE SURGICAL COMPANY INTERNATIONAL BV; stryker medical; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 8439223
• MDR Text Key: 139433770
• Report Number: 8439223
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2019,03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MA1100-PM
• Device Catalogue Number: MA1100-PM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA