ROGUE

Additional Manufacturer Narrative

THE COMPONENT WAS REDESIGNED TO MAKE IT STRONGER. TEST REPORTS TR-0843, TR-0862 VERIFY ACCEPTABILITY OF INDICES 3-7. ECO 1562 SHOWS THIS NEW DESIGN IS ADEQUATE IN FATIGUE, A 4" DROP IN FATIGUE, AND DROPPING OFF A 6" CURB.

Description of Event or Problem

IT WAS REPORTED THAT THE TOWER SYSTEM COMPONENTS BROKE RESULTING IN THE REAR WHEELS SEPARATING FROM THE CHAIR FRAME WHEN GOING DOWN A 6 INCH CURB. NO INJURY WAS REPORTED AS A RESULT.

Additional Manufacturer Narrative

ALL REQUIRED TESTING REQUIRED BY FDA WAS PERFORMED AND PASSED. THE WHEELCHAIR WAS ADJUSTED BY THE END USER IN A NON TYPICAL SETUP. A CAPA HAS BEEN OPENED TO ADDRESS WHAT IS NEEDED TO PREVENT RECURRENCE.

Description of Event or Problem

IT WAS REPORTED STATED THE TOWER SYSTEM COMPONENTS BROKE RESULTING IN THE REAR WHEELS SEPERATING FROM THE CHAIR FRAME WHEN GOING DOWN A CURB.