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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC SYSTEM, THERMAL REGULATING

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STRYKER MEDICAL-KALAMAZOO ALTRIX, DOMESTIC SYSTEM, THERMAL REGULATING Back to Search Results
Model Number 8001
Device Problem Excessive Cooling (2932)
Patient Problem Alteration in Body Temperature (4568)
Event Date 12/19/2021
Event Type  malfunction  
Event Description
It was reported the patient was being cooled to a target temp of 36 degrees but the device overshot the temperature and cooled the patient to 35. 1 degrees. The device alarmed and began warming the patient back up to target temperature. There are no reports of adverse consequences as a result of this event.
 
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Brand NameALTRIX, DOMESTIC
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 Key13054398
MDR Text Key282626588
Report Number0001831750-2021-01658
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152266
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 03/11/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received12/19/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/07/2019
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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