MERITS HEALTH PRODUCTS CO., LTD

Additional Manufacturer Narrative

THIS IS A FOLLOW UP REPORT TO UPDATE OUR STATUS. IN ORDER TO FOLLOW UP, WE HAVE ISSUED INTERNAL CAPA AND ALSO CONDUCTED THE VALIDATION TESTS. (SEE APPENDIX I FOR THE CAPA FORM NO. 20201002 AND RELATED TEST REPORTS ATTACHED). NOW IT IS CONFIRMED THAT THE IMPROVEMENT IS EFFECTIVE SO WE ARE NOW STARTING TO PLAN FOR THE FIELD CORRECTION. OUR USA LOCAL DISTRIBUTOR HAS SENT NOTIFICATION LETTER TO THE CUSTOMERS. THE LETTER IDENTIFIED THE AFFECTED PRODUCT AND REQUESTED THE CUSTOMERS TO COMPLETE THE FORM. DUE TO THE CORONAVIRUS OUTBREAK, THERE WILL BE A DELAY ON THE IMPLEMENTATION OF THE FIELD CORRECTION AND INFORMATION WAS PASS OUT ACCORDINGLY. - ATTACHMENT: [20201002 CAPA 22020-3-25 ENG V1.PDF, APPENDIX 7 OF CAPA (RAR-E03-02) RISK MANAGEMENT REPORT.PDF].

Description of Event or Problem

USER WAS RIDING FROM FIRST FLOOR TO THE SECOND WHEN APPROXIMATELY HALFWAY ALONG THE TRACK, THE PINION GEAR DISENGAGED FROM THE GEAR RACK ALLOWING THE LIFT TO SLIDE DOWNWARD. THE PINION GEAR RE-ARRANGED WITH THE GEAR RACK APPROXIMATELY HALF OF THE INITIAL TRAVEL BRINGING THE LIFT TO A SLOP. THE USER WAS SHAKEN BY THE MALFUNCTION AND SUFFERED MINOR BRUISING TO HIS ARM, NO HOSPITALIZATION WAS REQUIRED.

Additional Manufacturer Narrative

BASE ON THE PROVIDED S/N, WE CHECKED THE FINAL INSPECTION RECORD AND IT WAS CONFIRMED THAT IT PASS OUR FINAL INSPECTION. AFTER REVIEWING THE FAILURE PARTS, WE FOUND THAT WAS SWING HEAD ASSEMBLY WAS STUCK DUE TO THE DAMAGED BEARING. THE NEEDLE BEARING FALL OUT FROM THE BEARING RETAINER. THE BEARING OUTSIDE CASE WAS ALSO SLIGHTLY DEFORMED BY A SCREW WHICH WENT THROUGH A HOLE ON THE TOP OF THE SWING HEAD ASSEMBLY. AFTER INVESTIGATING THE PROBLEM, WE FOUND THE ROOT CAUSE TO THIS FAILURE IS AS BELOW: (1) THE TOLERANCE BETWEEN THE SWING HEAD HOLE AND THE BEARING WAS TOO BIG OR THE INSUFFICIENT ROUNDNESS WHICH CAUSE THE BEARING MIGHT BE ROTATING INSIDE THE HOLE AND PREMATURELY FAIL. (2)THE SCREW WHICH WENT THROUGH THE HOLE ON THE TOP ON THE SWING HEAD WAS OVERTIGHTENED AND DAMAGE THE BEARING CASE. BASE ON OUR INITIAL INVESTIGATION, OUR IMPROVEMENT PLAN IS AS BELOW: REVISE THE HOLE TOLERANCE OF THE SWING HEAD HOLE. CANCEL THE SCREW WHICH WENT THROUGH THE SWING HEAD HOLE AND REPLACE IT WITH A WELDED NUT, TO AVOID THE DAMAGE ON THE BEARING. UPGRADE THE BEARING FROM STAMPING TO MACHINING TYPE. WE WILL CONDUCT FURTHER VERIFICATION AND VALIDATION ACTION FOR THIS IMPROVEMENT AND ALSO WILL START TO WORK ON OUR REPAIR PLAN FOR THE SOLD UNITS IN THE FIELD.

Description of Event or Problem

USER WAS RIDING FROM FIRST FLOOR TO THE SECOND WHEN APPROXIMATELY HALFWAY ALONG THE TRACK, THE PINION GEAR DISENGAGED FROM THE GEAR RACK ALLOWING THE LIFT TO SLIDE DOWNWARD. THE PINION GEAR RE-ARRANGED WITH THE GEAR RACK APPROXIMATELY HALF OF THE INITIAL TRAVEL BRINGING THE LIFT TO A SLOP. THE USER WAS SHAKEN BY THE MALFUNCTION AND SUFFERED MINOR BRUISING TO HIS ARM, NO HOSPITALIZATION WAS REQUIRED.