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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.
 
Manufacturer Narrative
Upon further investigation it was found that the mark on the patient's skin went away the next day and was a minor pressure injury from using the blanket for an extended period of time.The customer did not allege any defects with the blanket that would have contributed to the skin marks.H3 other text : user facility did not allege a device 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.
 
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Brand Name
MISTRAL-AIR BLOWER, SYK
Type of Device
SYSTEM THERMAL REGULATING
Manufacturer (Section D)
TSCI BV DBA THE 37COMPANY
beeldschermweg 6f
ah amersfoort 03821
NL  03821
MDR Report Key10332418
MDR Text Key202039304
Report Number3003312341-2020-00003
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K101705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/01/2020
1 Device was Involved in the Event
1 Patient was 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 No Information
Device Catalogue NumberMA1200-PM
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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