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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO TRURIZE; CHAIR, POSITIONING, ELECTRIC
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STRYKER MEDICAL-KALAMAZOO TRURIZE; CHAIR, POSITIONING, ELECTRIC Back to Search Results
Catalog Number 3333000000
Device Problems Device Alarm System (1012); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/10/2017
Event Type  malfunction  
Event Description
It was reported that the chair exit would not alarm due to the actuator being out of alignment.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
Manufacturer Narrative
It was initially reported the chair exit was not functional, however the investigation found that the allegation was that the chair exit was not alarming at the nurse's station.This issue could not be confirmed upon evaluation of the unit, as the inspection occurred at the distribution center, and not at the user facility where it could be tested with their nurse call system.However, the evaluation did determine the chair exit was functioning properly.
 
Event Description
It was reported that the chair exit would not alarm due to the actuator being out of alignment.No patient was affected and no adverse consequence or clinically relevant delay in treatment was reported.
 
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Brand Name
TRURIZE
Type of Device
CHAIR, POSITIONING, ELECTRIC
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
mary klaver
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key7006400
MDR Text Key92199972
Report Number0001831750-2017-00504
Device Sequence Number1
Product Code INO
Combination Product (y/n)N
Reporter Country CodeUS
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 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number3333000000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received10/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2016
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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