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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 03/31/2024
Event Type  malfunction  
Event Description
It was reported that the patient is warming but the temperature is slowly decreasing.The target temperature is 36.5, patient temperature is 33.9, the patient temperature was 34.4.The patient is an infant in an isolate.A delay in warming time was reported, however no adverse consequence or clinically relevant delay in treatment was 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
brian thompson
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key19165995
MDR Text Key340964966
Report Number0001831750-2024-00686
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
Combination Product (y/n)N
Reporter Country CodeCA
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
Report Date 04/23/2024
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 03/31/2024
Initial Date FDA Received04/23/2024
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
Patient Sequence Number1
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