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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
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 02/12/2019
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that the hose is leaking at the connection joint on to the patient surface.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
 
Additional Manufacturer Narrative
Updated the catalog number and serial number.The issue was resolved for the customer by providing the customer with new hoses.
 
Event or Problem Description
It was reported that the hose is leaking at the connection joint on to the patient surface.The patient was not adversely affected and no clinically relevant delay in treatment was reported.
 
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Brand Name
ALTRIX, DOMESTIC
Common Device Name
SYSTEM, THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key8414325
Report Number0001831750-2019-00280
Device Sequence Number16701204
Product Code DWJ
UDI-Device Identifier07613327175325
UDI-Public07613327175325
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K152266
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 04/11/2019
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
Operator of Device No Information
Device Catalogue Number8001000001
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Initial Date Received by Manufacturer 02/13/2019
Supplement Date Received by Manufacturer02/13/2019
Initial Report FDA Received Date03/12/2019
Supplement Report FDA Received Date04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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