CATALYST 4

Description of Event or Problem

A COMPLAINT WAS REPORTED ON (B)(6) 2023 STATING THAT THE DEALER CLAIMS THE RIGHT CASTER CAME OFF OF THE CHAIR DURING PROPULSION. THE END USER FELL DOWN WITH THE CHAIR AND SUFFERED MILD BRUISING AND PAIN. IT WAS FURTHER REPORTED THAT IT WAS THE RIGHT SIDE CASTER HOUSING BOLT AND ECCENTRIC NUT THAT HAD FELL OUT. "THE BOTTOM NUT (ECCENTRIC NUT?) AND BOLT ON THE CASTER ASSEMBLY FELL OFF AND CAUSED THE CASTER TO PIVOT AND THE CHAIR TIPPED OVER WITH THE PATIENT STILL IN THE CHAIR." NO FURTHER INFORMATION WAS OBTAINED.

Additional Manufacturer Narrative

THIS REPORT IS BEING FILED OUT OF AN ABUNDANCE OF CAUTION DUE TO THE RESIDUAL RISK IDENTIFIED IN THE RISK ASSESSMENT PERFORMED ON THIS MODEL AND FAILURE MODE. IF THE FAILURE WERE TO REOCCUR, IT COULD RESULT IN MORE SERIOUS INJURY TO A USER.