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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.
 
Manufacturer Narrative
It was initially reported that a patient expired a few hours after the device displayed an alarm.Upon further investigation it was confirmed that the patient's death was not related to the device.Section b5 has been updated to reflect this.
 
Event Description
It was reported that the device displayed a patient temperature alarm.The user facility changed the machine but the patient expired later.Upon follow up with the user facility it was confirmed that the patient's death was not related to the altrix device.A troubleshooting investigation is still ongoing.
 
Manufacturer Narrative
Upon inspection by a stryker field service technician it was found that the device alarm would cause an interruption in heating/cooling therapy, which is not a reportable issue.
 
Event Description
It was reported that the device displayed a patient temperature alarm.The user facility changed the machine but the patient expired later.Upon follow up with the user facility it was confirmed that the patient's death was not related to the altrix device.The device was evaluated by a stryker field service technician where it was found that the alarm would cause an interruption in heating/cooling therapy which is not a reportable issue.
 
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Brand Name
ALTRIX, 220-240V/50HZ, TYPE F
Type of Device
SYSTEM THERMAL REGULATING
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key11315202
MDR Text Key231419017
Report Number0001831750-2021-00592
Device Sequence Number1
Product Code DWJ
Combination Product (y/n)N
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
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 No Information
Device Catalogue Number8001000015
Was Device Available for Evaluation? Yes
Date Manufacturer Received02/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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