MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY MISTRAL-AIR PLUS (115V) BLOWER; SYSTEM, THERMAL REGULATING

Model Number MA1100-PM

Device Problems Device Alarm System (1012); Thermal Decomposition of Device (1071)

Patient Problem Burn, Thermal (2530)

Event Date 03/13/2019

Event Type  malfunction  

Event Description

It was reported that while utilizing the blanket during an operating room procedure the customer allegedly noticed that their ecm/bovie machine was alarming.Biomed was called and noticed that the ma1100 was also alarming.The unit was pulled from the operating room and upon inspection the bme technician happened to notice that when the bovie pad was connected to him and someone else pushed the bovie pen he could potentially burn/melt the reflective layer of the ma3320-pm blanket.This only appeared to occur when the tip of one of his fingers touched the blanket.If more than just a directed piece of his finger touched the blanket it would not occur.However, when putting just the tip of his finger on the blanket it would allegedly burn/melt every time.The bme technician allegedly received a burn with no required medical intervention.No patient injury was identified during the initial report of problem.

Manufacturer Narrative

After investigation, the cause for the alarm on the device was found not to be related to a defect with the device (no defect alleged).Although no defect was alleged, it was identified in an additional document review and the labeling review that the alarm may have been caused by electromagnetic interference between the electrosurgery device and the blower as the separation distance between the devices was not sufficient for the power output and frequency of the electrosurgery device.This issue was resolved for the customer by providing investigation results and recommending that the separation distance between the blower and the electrosurgery device be increased per the manual to resolve the alarm on the blower.After investigation, the cause for the alleged burn on the tip of the finger of the biomedical technician was found not to be related to a defect with the product (no defect alleged).It was identified through the inspection details and the labeling review that this issue may be attributed to the skin coming into contact with the reflective surface, which is cautioned against in the instructions for use.The biomedical technician did not seek any medical attention and did not self treat his injury.This issue was resolved by providing information that the skin should not come into contact with the reflective surface as indicated in the instructions for use.

Event Description

It was reported that while utilizing the blanket during an operating room procedure the customer allegedly noticed that their ecm/bovie machine was alarming.Biomed was called and noticed that the ma1100 was also alarming.The unit was pulled from the operating room and upon inspection the bme technician happened to notice that when the bovie pad was connected to him and someone else pushed the bovie pen he could potentially burn/melt the reflective layer of the ma3320-pm blanket.This only appeared to occur when the tip of one of his fingers touched the blanket.If more than just a directed piece of his finger touched the blanket it would not occur.However, when putting just the tip of his finger on the blanket it would allegedly burn/melt every time.The bme technician allegedly received a burn with no required medical intervention.No patient injury was identified during the initial report of problem.

• Brand Name: MISTRAL-AIR PLUS (115V) BLOWER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer (Section G): TSCI BV DBA THE 37COMPANY; beeldschermweg 6f; ah amersfoort 03821 ; NL 03821
• Manufacturer Contact: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8500302
• MDR Text Key: 141908754
• Report Number: 3003312341-2019-00002
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: ET37MA1100PM03
• UDI-Public: +ET37MA1100PM03
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• 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?: No
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1