MISTRAL AIR WARMING UNIT MA1100-PM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for MISTRAL AIR WARMING UNIT MA1100-PM manufactured by The Surgical Company International Bv.

Event Text Entries

[139433770] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 8439223
• MDR Report Key: 8439223
• Date Received: 2019-03-21
• Date of Report: 2019-03-15
• Date of Event: 2019-03-12
• Report Date: 2019-03-19
• Date Reported to FDA: 2019-03-19
• Date Reported to Mfgr: 2019-03-21
• Date Added to Maude: 2019-03-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MISTRAL AIR WARMING UNIT
• Generic Name: SYSTEM, THERMAL REGULATING
• Product Code: DWJ
• Date Received: 2019-03-21
• Model Number: MA1100-PM
• Catalog Number: MA1100-PM
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: THE SURGICAL COMPANY INTERNATIONAL BV
• Manufacturer Address: STRYKER MEDICAL 3800 E. CENTRE AVE. PORTAGE MI 49002 US 49002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-03-21