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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)
Event Date 12/28/2022
Event Type  Injury  
Event Description
It was reported that this unit is thought to have possibly burned a patient during surgery.The blanket was applied waist down, patient laying on their left side for approximately 4hrs during surgery.It was noted that the patient developed very red skin but no blisters on the right thigh area.It was reported that, though the injury was categorized by caregivers as "moderate injury" but treatment was required (cold, wet cloth was immediately placed on the right thigh).No further information regarding treatment is available at this time.
 
Manufacturer Narrative
The patient treated the injury using cooling rags/towels and prescribed silvadene, which relieved the redness.The unit was set to high (43°c) and the skin was not periodically observed due to the procedure (laparoscopic hand assisted nephrectomy-kidney removal) being sterile.A cloth blanket and sterile drape were placed on top of the blanket during the procedure.A sr.Staff medical science liaison was consulted, who advised that weight from blankets or sterile drapes can cause additional pressure and/or potentially reduce air flow, which may have caused or contributed to the alleged event.The account requested to have the unit evaluated, and a visual and functional inspection was performed by a technical support specialist.It was identified that there was no defect identified with the unit.
 
Event Description
It was reported that this unit is thought to have possibly burned a patient during surgery.The blanket was applied waist down, patient laying on their left side for approximately 4hrs during surgery.It was noted that the patient developed very red skin but no blisters on the right thigh area.It was reported that the injury was categorized by caregivers as moderate injury on the right thigh.The patient treated the injury using cooling rags/towels and prescribed silvadene, which relieved the redness.
 
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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
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 Key16150004
MDR Text Key307213835
Report Number3003312341-2023-00001
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171234
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberMA1200-PM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/28/2022
Initial Date FDA Received01/12/2023
Supplement Dates Manufacturer Received12/28/2022
Supplement Dates FDA Received04/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/12/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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