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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
Catalog Number 1460000000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 01/01/2020
Event Type  malfunction  
Manufacturer Narrative
This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.4 devices were evaluated in the field and the issue was confirmed; the devices had broken/damaged components.The devices were repaired and returned.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.
 
Event Description
This report summarizes 4 malfunction events, where it was reported the armrest collapsed.There was no patient involvement.
 
Manufacturer Narrative
The final device was not evaluated and no cause was determined, as the customer did not make the device accessible for testing.H3 other text : see h11.
 
Event Description
This report summarizes 4 malfunction events, where it was reported the armrest collapsed.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 Key10000419
MDR Text Key189786086
Report Number0001831750-2020-00357
Device Sequence Number1
Product Code INN
UDI-Device Identifier07613327282665
UDI-Public07613327282665
Combination Product (y/n)N
Number of Events Reported4
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number1460000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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