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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 Information (3190)
Patient Problem Alteration In Body Temperature (2682)
Event Date 07/21/2017
Event Type  malfunction  
Event Description
It was reported that the user facility was experiencing patient temperature deviation issues.
 
Manufacturer Narrative
There were no adverse consequences reported to the patient experiencing temperature deviation.The user facility was provided feedback on proper device operation.
 
Event Description
It was reported that the user facility was experiencing patient temperature deviation issues.
 
Manufacturer Narrative
Supplemental submitted to include udi.
 
Event Description
It was reported that the user facility was experiencing patient temperature deviation issues.
 
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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
kristen canter
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key6800331
MDR Text Key83098079
Report Number0001831750-2017-00332
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 03/29/2018
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 Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/21/2017
Initial Date FDA Received08/17/2017
Supplement Dates Manufacturer Received07/21/2017
07/21/2017
Supplement Dates FDA Received09/27/2017
03/29/2018
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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