NITRO SPRINT ROLLATOR

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED TO DRIVE DEVILBISS HEALTHCARE FOR EVALUATION AND CONFIRMED THAT THE LEFT BRAKE DOES NOT STOP MOVEMENT WHEN IN THE PARKING SETTING. THE LEFT BRAKE STILL ENGAGES THE WHEEL WHEN USING THE HAND BRAKE AND PARKING BRAKE; HOWEVER, THE WHEEL IS WORN AND SLIPS WHEN IN THE PARKING SETTING AND ADVISE THAT THE WHEEL BE REPLACED. THE BRAKES WORK AS INTENDED.

Description of Event or Problem

DRIVE DEVILBISS HEALTHCARE WAS NOTIFIED OF AN INCIDENT INVOLVING A ROLLATOR BY THE END USER'S DAUGHTER WHO STATED THAT THE BRAKES RELEASED WHILE THE END USER WAS SITTING IN IT CAUSING HER TO FALL BACKWARDS AND HIT HER HEAD ON THE SIDEWALK RESULTING IN HOSPITALIZATION AND DIAGNOSIS OF A BILATERAL BRAIN BLEED. THE INSTRUCTIONS FOR USE STATE: "REGULARLY CHECK THE SCREWS AND FASTENERS ON THE NITRO® ROLLATOR AND RETIGHTEN IF NECESSARY" AND "TEST THE BRAKE LEVER BEFORE OPERATING THE ROLLATOR. WHEN WHEELS ARE LOCKED, THE BRAKE PAD SHOULD PREVENT THE WHEELS FROM TURNING. WHEN THE BRAKES ARE RELEASED, THE WHEELS SHOULD TURN FREELY" AND "DRIVE DEVILBISS HEALTHCARE RECOMMENDS PERIODIC VISUAL INSPECTION OF THIS PRODUCT BY THE USER TO ENSURE THAT ALL PARTS AND HARDWARE ARE SECURE AND ALL COMPONENTS ARE IN GOOD WORKING ORDER AND NOT WORN, TORN, FRAYED, OR LOOSE." AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.