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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
Catalog Number 8001000001
Device Problems Insufficient Cooling (1130); Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/26/2024
Event Type  malfunction  
Event Description
It was reported that the patient skin was too cold.There was patient involvement, but no adverse consequences or clinically relevant delay in treatment reported.
 
Manufacturer Narrative
A stryker senior clinical nurse consultant explained to the customer that the top blanket was likely picking up ambient temperature and that the blankets were working to not cool the patient too fast.The customer agreed and removed the top blanket while moving the bottom blanket to the top of the patient, which resolved the issue.The unit cooled with no issue.Based on this information, it was likely not due to any component level malfunction.
 
Event Description
It was reported that the patient skin was not cold enough.There was patient involvement, but no adverse consequences or clinically relevant delay in treatment reported.
 
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Brand Name
ALTRIX, DOMESTIC
Type of Device
SYSTEM, 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
melissa simon
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19182898
MDR Text Key341064432
Report Number0001831750-2024-00687
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 Other
Type of Report Initial,Followup
Report Date 06/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/26/2024
Initial Date FDA Received04/25/2024
Supplement Dates Manufacturer Received03/26/2024
Supplement Dates FDA Received06/12/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/02/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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