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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 Device Fell (4014)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
Event Type  malfunction  
Event Description
This report summarizes 11 malfunction events, where it was reported the devices experienced armrest does not support weight.There was no patient involvement.
 
Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.11 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.There was no remedial action taken.This device is not labeled for single use.
 
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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
Manufacturer (Section G)
STRYKER MEDICAL-KALAMAZOO
3800 east centre avenue
portage MI 49002
Manufacturer Contact
melanie shepard
3800 east centre avenue
portage, MI 49002
2693292100
MDR Report Key14207740
MDR Text Key290164937
Report Number0001831750-2022-00441
Device Sequence Number1
Product Code INN
UDI-Device Identifier07613327282665
UDI-Public07613327282665
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported11
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number1460-000-000
Device Catalogue Number1460000000
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Yes
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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