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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO ALTRIX, 220-240V/50HZ, TYPE F SYSTEM THERMAL REGULATING
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STRYKER MEDICAL-KALAMAZOO ALTRIX, 220-240V/50HZ, TYPE F SYSTEM THERMAL REGULATING Back to Search Results
Catalog Number 8001000015
Device Problems Insufficient Cooling (1130); Insufficient Heating (1287); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/02/2021
Event Type  malfunction  
Event Description
It was reported that the device displayed a patient temperature alarm. The user facility changed the machine but the patient expired later; it is unknown at this time what caused the death.
 
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Brand NameALTRIX, 220-240V/50HZ, TYPE F
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
kelsey barla
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key11315202
MDR Text Key231419017
Report Number0001831750-2021-00592
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number8001000015
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/02/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/11/2021 Patient Sequence Number: 1
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