FDA Adverse Event Malfunction Summary report: N

MISTRAL AIR WARMING UNIT

MDR report key: 8439223 · Received March 21, 2019

Report

Report Number
8439223
Event Type
Malfunction
Date Received
March 21, 2019
Date of Event
March 12, 2019
Report Date
March 15, 2019
Manufacturer
THE SURGICAL COMPANY INTERNATIONAL BV
Product Code
DWJ
Product Problem
Yes
Report Source
User Facility report
Reporter Location
PA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
233747 MISTRAL AIR WARMING UNIT SYSTEM, THERMAL REGULATING DWJ THE SURGICAL COMPANY INTERNATIONAL BV MA1100-PM

Patients

Seq Age Sex Outcome Treatment
1 22265 DA