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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 Electrical /Electronic Property Problem (1198)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/06/2022
Event Type  malfunction  
Event Description
It was reported that the devices failed the electrical testing which has the potential to cause ac shock.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
Upon further investigation of the reported event, it was discovered that the issue was likely due to user error.
 
Event Description
It was reported that the devices failed the electrical testing which has the potential to cause ac shock.No patient was affected and 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
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
melissa millard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key14834438
MDR Text Key295326623
Report Number0001831750-2022-00598
Device Sequence Number1
Product Code DWJ
UDI-Device Identifier07613327277555
UDI-Public07613327277555
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 Other
Type of Report Initial,Followup
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number8001
Device Catalogue Number8001000001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/17/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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