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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 Excessive Heating (4030)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by 3rd party.
 
Event Description
It was reported that the device was being used to cool a patient and then the device switched to heating. It was reported that the temperature heated up to 106 degrees before the hospital staff noticed. The patient was reported to be recovering, however patient injury cannot be confirmed.
 
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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 Key10203256
MDR Text Key196956357
Report Number0001831750-2020-00637
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 06/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMTA6900
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/26/2004
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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