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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL-KALAMAZOO PRIME TC SWING-AWAY MODEL; CHAIR, ADJUSTABLE, MECHANICAL
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STRYKER MEDICAL-KALAMAZOO PRIME TC SWING-AWAY MODEL; CHAIR, ADJUSTABLE, MECHANICAL Back to Search Results
Model Number 1460-000-000
Device Problem Mechanical Problem (1384)
Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2020
Event Type  malfunction  
Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.The device was evaluated in the field and the issue was confirmed; there was a broken/damaged component.The device was repaired and returned.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the device had reduced brake force.There was no patient involvement.
 
Manufacturer Narrative
It was originally reported that this device had a brake failure; however, after further clarification from the service technician it was determined the device had excessive noise.This issue is not reportable.
 
Event Description
This report summarizes 1 malfunction event, where it was reported the device had reduced brake force.There was no patient involvement.
 
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Brand Name
PRIME TC SWING-AWAY MODEL
Type of Device
CHAIR, ADJUSTABLE, MECHANICAL
Manufacturer (Section D)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
MDR Report Key10325517
MDR Text Key200394950
Report Number0001831750-2020-00835
Device Sequence Number1
Product Code INN
UDI-Device Identifier07613327282665
UDI-Public07613327282665
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1460-000-000
Device Catalogue Number1460000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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