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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 Problem Insufficient Heating (1287)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2024
Event Type  malfunction  
Event Description
It was reported that the temperature deviation alarm was occurring due to the patient temperature being more than 0.5 degrees from target temperature.It was reported that the device was in auto mode, with a rectal temperature of 35.4 and is correlating to a secondary temperature.The wraps are cool to the touch and the water temperature is 40 degrees.It was reported that they were originally cooling the patient and met the target temperature and now were re-warming however, the patient was not warming to the goal as fast as expected.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
 
Event Description
It was reported that the temperature deviation alarm was occurring due to the patient temperature being more than 0.5 degrees from target temperature.It was reported that the device was in auto mode, with a rectal temperature of 35.4 and is correlating to a secondary temperature.The wraps are cool to the touch and the water temperature is 40 degrees.It was reported that they were originally cooling the patient and met the target temperature and now were re-warming however, the patient was not warming to the goal as fast as expected.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Information provided by the user facility identified that the device was rewarming the patient to counteract an underlying patient condition, which resulted in the patient's temperature dropping.Based on this information,it was determined that the temperature deviation alarm was likely not due to any component level malfunction and instead due to the patient's underlying condition.This issue was resolved for the customer by ensuring that the device was functioning correctly and recommending the nurse confer with the providers regarding the patient's condition.The manufacturing date section h4 and the h6 codes have been corrected.
 
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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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19117763
MDR Text Key340294049
Report Number0001831750-2024-00362
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 Nurse
Type of Report Initial,Followup
Report Date 06/11/2024
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? Yes
Initial Date Manufacturer Received 04/05/2024
Initial Date FDA Received04/16/2024
Supplement Dates Manufacturer Received04/05/2024
Supplement Dates FDA Received06/11/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/14/2023
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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