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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.
 
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Brand NameALTRIX, DOMESTIC
Type of DeviceSYSTEM, 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 Key10635624
MDR Text Key210011261
Report Number0001831750-2020-00924
Device Sequence Number1
Product Code DWJ
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
Type of Report Initial,Followup
Report Date 01/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/08/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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