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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2021
Event Type  malfunction  
Event Description
It was reported that the altrix was set to cool the patient to 33 degrees.The alarm sounded when the patient was at 32.4 degrees.While the nurse was trouble shooting, the patient continued to cool to 30.4 degrees.It was reported that this caused a delay in treatment, however no adverse consequences were reported.
 
Event Description
It was reported that the altrix was set to cool the patient to 33 degrees.The alarm sounded when the patient was at 32.4 degrees.While the nurse was trouble shooting, the patient continued to cool to 30.4 degrees.It was reported that this caused a delay in treatment, however no adverse consequences were reported.
 
Manufacturer Narrative
The device was not available for evaluation and no further information was provided.Corrected the manufacturing date in section h4 h3 other text : device not accessible for evaluation.
 
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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
MDR Report Key11959997
MDR Text Key254962353
Report Number0001831750-2021-00944
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
Combination Product (y/n)N
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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