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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO CAPITAL HYPER HYPOTHERMIA SYSTEM, THERMAL REGULATING Back to Search Results
Catalog Number MTA6900
Device Problem Temperature Problem (3022)
Patient Problems Ischemia (1942); Tissue Breakdown (2681); Alteration In Body Temperature (2682)
Event Date 11/12/2013
Event Type  Injury  
Manufacturer Narrative
Additional information surrounding the event and a visual and functional inspection of the device was not available.
 
Event Description
It was alleged in mw5067491 that a patient was being treated for elevated temperatures with a medi therm device. It was alleged that leg wraps were secured over sequential compression device wraps over each leg below the knee and above the ankle. It was alleged that chilled water was circulated continuously for 25 hours through the leg wraps with water temperatures as low as 40 degrees. It was alleged that the patient suffered thermal tissue injuries and ischemia to both legs requiring below the knee amputation of both legs.
 
Manufacturer Narrative
Additional information surrounding the event and a visual and functional inspection of the device was not available.
 
Event Description
It was alleged in mw5067491 that a patient was being treated for elevated temperatures with a medi therm device. It was alleged that leg wraps were secured over sequential compression device wraps over each leg below the knee and above the ankle. It was alleged that chilled water was circulated continuously for 25 hours through the leg wraps with water temperatures as low as 40 degrees. It was alleged that the patient suffered thermal tissue injuries and ischemia to both legs requiring below the knee amputation of both legs.
 
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Brand NameCAPITAL HYPER HYPOTHERMIA
Type of DeviceSYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6516596
MDR Text Key73556942
Report Number0001831750-2017-00139
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/20/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberMTA6900
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 Received03/27/2017
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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