W467 ROLLATOR

Description of Event or Problem

(B)(4).

Additional Manufacturer Narrative

THE ROLLER DEVICE INVOLVED IN THIS MDR WAS RETURNED TO THE US IMPORTER/ DISTRIBUTOR OF MERITS HEALTHCARE INDUSTRIES. AN INITIAL INSPECTION WAS PERFORMED BY THE IMPORTER/ DISTRIBUTOR AND THE DEVICE WAS THEN SENT TO THE MFR, MERITS HEALTHCARE INDUSTRIES ((B)(4)). THE MFR MERITS HEALTHCARE INDUSTRIES ((B)(4) WILL PERFORM FURTHER DEVICE INSPECTION AND ANALYSIS UPON RECEIPT OF THE DEVICE AT THEIR LOCATION AND WILL THEN BE ABLE TO CONCLUDE THE INVESTIGATION. AS PART OF THE COMPLAINT INVESTIGATION, THE MFR REVIEWED ORIGINAL INSPECTION/ TEST REPORTS THE FINISHED ROLLATOR DEVICE (SEE APPENDIX I - FATIGUE TEST REPORT FOR ROLLATOR - DATED (B)(6) 2010). THE FINAL ASSEMBLED DEVICE PASSED THE FATIGUE TEST. WE HAVE REVIEWED OUR COMPLAINT RECORDS AND DID NOT FIND REPORTS OF SIMILAR COMPLAINTS FOR THIS ROLLATOR MODEL W467 OR OTHER ROLLATOR MODELS. WE DID NOT INITIATE ANY MARKET RECALLS FOR THE ROLLATOR. WE CURRENTLY DO NOT HAVE UNSHIPPED COMPLETE ROLLATOR DEVICES IN STOCK. HOWEVER, WE HAVE INVENTORY OF SAME WHEELS PARTS AND PERFORMED AN IMPACT TEST ON THE RANDOMLY SELECTED WHEEL FROM OUR EXISTING INVENTORY. THE WHEEL PASSED THE IMPACT TEST (APPENDIX II - IMPACT TEST OF THE WHEEL). WE PULLED OUT OUR SAMPLE FROM THE SHOWROOM AND HAVE CONDUCTED ANOTHER FATIGUE TEST ON THE COMPLETE UNIT HAS PASS THE FATIGUE TEST. (SEE APPENDIX III, FATIGUE TEST ON FINISHED UNIT).