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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 Insufficient Cooling (1130)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2022
Event Type  malfunction  
Event Description
It was reported that during therapy, blanket/wrap contact surface temperature not cold enough.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
The device was evaluated and it was determined that the device's cooling compressor assembly needed to be replaced.
 
Event Description
It was reported that during therapy, blanket/wrap contact surface temperature not cold enough.No patient was affected and 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
melissa millard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key15395886
MDR Text Key304802958
Report Number0001831750-2022-00914
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 11/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/09/2022
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 Received08/15/2022
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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