ROLLATOR 23.5 IN 400LB 5 IN WHEELS

Additional Manufacturer Narrative

BASED ON SUPPLIER INVESTIGATION, DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD LEAD TO THE REPORTED INCIDENT. THE ROLLATOR WAS RECEIVED FOR INVESTIGATION PARTIALLY DISASSEMBLED. AFTER ASSEMBLING THE BACKREST AND THE ARMREST, NO ABNORMALITY WAS FOUND IN THE MAIN FRAME, BUT THE RIGHT FRONT WHEEL WAS SKEWED INWARD. THE SUPPLIER USED A STEEL RULER TO CHECK THE STRAIGHTNESS OF THE FRAME BODY, NEITHER THE LEFT OR THE RIGHT TUBES HAVE ANY DEFORMITY. THEY VISUALLY CHECKED THE RIGHT FRONT WHEEL AND THE OUTER SURFACE OF THE WHEEL FORK HAD OBVIOUS IMPACT MARKS AND THE SURFACE AND BOTTOM OF THE WHEEL FORK WERE OBVIOUSLY DAMAGED. THE SUPPLIER USED A RIGHT-ANGLE RULER TO CHECK THE RIGHT FRONT WHEEL WHICH SHOWED THAT THE WHEEL IS SKEWED INWARD AND NOT PERPENDICULAR TO THE GROUND. THEY DISASSEMBLED THE RIGHT FRONT WHEEL AND FOUND THAT THE DOUBLE-HEADED SCREW WAS BENT. IT APPEARS THAT THE SIDE OF THE WHEEL WAS IMPACTED, CAUSING THE FIXED SCREW TO BEND CAUSING THE WHEEL TO SKEW INWARD. AFTER REPLACING THE RIGHT FRONT WHEEL, THE ROLLATOR MOVES SMOOTHLY. FROM THE INVESTIGATION THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. AT THIS TIME NO ADDITIONAL ACTION WILL BE TAKEN, BUT WE WILL CONTINUE TO MONITOR THE TREND OF THIS TYPE OF INCIDENT.

Additional Manufacturer Narrative

BASED ON THE SUPPLIER¿S INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY EXCEPTION THAT COULD HAVE LED TO THE REPORTED INCIDENT. THE SUPPLIER REVIEWED THE DEVICE MASTER RECORD AND THERE WERE NO DESIGN CHANGES, PRODUCTION PROCESS CHANGES OR MATERIAL CHANGES. AS THE DEVICE INVOLVED IN THIS INCIDENT WAS NOT AVAILABLE FOR FURTHER INVESTIGATION, THE ROOT CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. THE COMPLAINT INFORMATION WAS PROVIDED TO THE RELEVANT SECTORS FOR THEIR AWARENESS. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION THE COMPLAINT INVESTIGATION WILL BE REOPENED.

Description of Event or Problem

PER (B)(6) PHARMACY, THE END USER WAS USING THE ROLLATOR WALKING ON A SIDE WALK WHEN IT REPORTEDLY WENT OUT FROM UNDER HER AND BENT. SHE WAS NOT INJURED, NO OTHER INFORMATION AVAILABLE.