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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 04/19/2023
Event Type  malfunction  
Event Description
It was reported that the altrix over shot patient target temp.Patient set temperature was 36, patient temperature was 35.The rn double checked the temperature of the foley which was reading 35.5 and the rectal temperature was reading 35.3.The altrix was in max auto, with a water temperature of 33.4 despite the patient temperature being cooler than set temperature.Rn has all hoses attached and all circles are green on the monitor.Therapy had been started 6 hours prior.No other alarms noted.Rn confirmed temperature sources are secure in position.The water temperature was dropping despite the patient temperature remaining less than target set temperature.
 
Manufacturer Narrative
A visual and functional inspection was performed by a field service technician.It was identified that the unit maintained temperature appropriately.A senor clinical nurse consultant evaluated the unit¿s extracted data.It was determined that the unit operated as intended, with no known defect found.
 
Event Description
It was reported that the altrix over shot patient target temp.Patient set temperature was 36, patient temperature was 35.The rn double checked the temperature of the foley which was reading 35.5 and the rectal temperature was reading 35.3.The altrix was in max auto, with a water temperature of 33.4 despite the patient temperature being cooler than set temperature.Rn has all hoses attached and all circles are green on the monitor.Therapy had been started 6 hours prior.No other alarms noted.Rn confirmed temperature sources are secure in position.The water temperature was dropping despite the patient temperature remaining less than target set temperature.
 
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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 Key16898822
MDR Text Key314896992
Report Number0001831750-2023-00646
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 06/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received04/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2022
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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