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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 Heating (4030)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  malfunction  
Event Description
It was reported that the temperature deviation alarm occurred after the patient had been on for 9 hours.It was reported that the machine was functioning well and then the patient temperature increased to 36.6 with a goal temperature on auto at 36.The water temperature was cooler than the patient when the patient temperature started to come down.Once the patient temperature was at 36.5 the alarm turned off.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The product met specifications at the time of evaluation as no component level defect was found with the product and the unit worked to specification.
 
Event Description
It was reported that the temperature deviation alarm occurred after the patient had been on for 9 hours.It was reported that the machine was functioning well and then the patient temperature increased to 36.6 with a goal temperature on auto at 36.The water temperature was cooler than the patient when the patient temperature started to come down.Once the patient temperature was at 36.5 the alarm turned off.The patient was not adversely affected and no 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
MDR Report Key10635624
MDR Text Key210011261
Report Number0001831750-2020-00924
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 01/06/2021
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 Operator No Information
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received10/06/2020
Supplement Dates Manufacturer Received09/15/2020
Supplement Dates FDA Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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