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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TSCI BV DBA THE 37COMPANY MISTRAL-AIR BLOWER, SYK SYSTEM THERMAL REGULATING
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TSCI BV DBA THE 37COMPANY MISTRAL-AIR BLOWER, SYK SYSTEM THERMAL REGULATING Back to Search Results
Catalog Number MA1200-PM
Device Problem Excessive Heating (4030)
Patient Problems Burn(s) (1757); Skin Discoloration (2074); Skin Irritation (2076); Skin Inflammation/ Irritation (4545)
Event Date 06/30/2020
Event Type  malfunction  
Event Description
It was reported that a patient developed a possible burn or heat mark 12 inches in length on their calf after using a tube blanket with a mistral air blower during a procedure. The unit was in use from 12:30pm-3:15pm and set at 38 degrees celsius. The skin did not blister and no medical treatment was required. Attempts have been made to reach the customer for more information; however, the customer has not responded to these attempts.
 
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Brand NameMISTRAL-AIR BLOWER, SYK
Type of DeviceSYSTEM 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
kelsey barla
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key10332418
MDR Text Key202039304
Report Number3003312341-2020-00003
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMA1200-PM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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