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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 Problems Insufficient Cooling (1130); Insufficient Heating (1287); Excessive Cooling (2932); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  malfunction  
Event Description
It was reported that the altrix was having a hard time controlling the patient temperature.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was originally reported that the altrix was having a hard time controlling the patient temperature.However, upon further communication, it was discovered that the altrix was working was intended and no malfunction or defect was alleged.Per 21 cfr 820 this does not meet the definition of a reportable complaint as there was no medical device product malfunction, adverse event, or patient involvement.
 
Event Description
It was originally reported that the altrix was having a hard time controlling the patient temperature.However, upon further communication, it was discovered that the altrix was working was intended and no malfunction or defect was alleged.
 
Manufacturer Narrative
This supplemental record is being filed to correct the reportability and to correct the section h codes.
 
Event Description
It was reported that during therapy, blanket/wrap contact surface temperature became too cold.There was patient involvement, but no adverse consequence or clinically relevant delay in treatment was reported.
 
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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
MDR Report Key12339277
MDR Text Key267164585
Report Number0001831750-2021-01302
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
Combination Product (y/n)N
PMA/PMN Number
K152266
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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