Description of Event or Problem · 0
MY SEVERELY DISABLED CHILD'S LIFT STOPPED WORKING SOMETIME IN (B)(6) OF 2021. I WENT ONLINE TO RESEARCH HOW TO TROUBLESHOOT THE LIFT SINCE MY SON'S CARE IS TOTALLY DEPENDENT ON THIS MEDICAL DEVICE. THAT IS WHEN I DISCOVERED THAT THERE WAS A RECALL FOR THE PRISM C300 LIFT SINCE 2017 BUT I WAS NEVER NOTIFIED OF THIS SAFETY RECALL. ACCORDING TO THE HEALTH DEPARTMENT RECALL "THERE HAVE BEEN 17 OVERSEAS REPORTS OF THE DRIVE GEAR SHAFT ON THESE DEVICES BREAKING AND IN THREE OF THOSE CASES THE FREE-FALL PROTECTION SYSTEM DID NOT ENGAGE PROPERLY". I IMMEDIATELY REACHED OUT TO THE (B)(4) COMPANY AFTER READING THIS AND SPOKE TO CUSTOMER SERVICE LEAD, (B)(6). WE PROCEEDED TO EXCHANGE EMAILS AND SHE NOTIFIED ME THAT THE LIFT WOULD BE REPLACED DUE TO RECALL. I WAS LED TO BELIEVE THAT THIS LIFT WOULD BE REPLACED BECAUSE AS PER HER EMAIL THEY HAD THE LIFT BUT WERE LOOKING FOR AN INSTALLER IN THE (B)(6). AFTER SEVERAL MONTHS OF GETTING THE RUNAROUND WITH EXCUSES THEY FINALLY STOPPED CONTACTING ME ALTOGETHER. I THEN REACHED OUT TO (B)(6) WITH MEDICAID SUPERIOR HEALTH AND SHE WAS ALSO UNABLE TO REACH A SOLUTION. IN (B)(6) 2021, (B)(6) FROM (B)(4), NOTIFIED ME THAT THEY WOULD NOT BE ASSISTING US ANY LONGER IN REPLACING THE RECALLED LIFT. THIS MEDICAL DEVICE IS CRUCIAL TO MY SON'S CARE AND WE WILL NEED IT REPLACED JUST AS MENTIONED IN THE HEALTH DEPARTMENT, "ALL PRISM MEDICAL P300 AND C300 CEILING HOISTS MANUFACTURED SINCE 8 JUNE 2015 HAVE BEEN UPGRADED TO CORRECT THESE ISSUES". WE CAN NOT AFFORD TO USE THIS DEVICE AS IT COULD POTENTIALLY RESULT IN A SEVERE INJURY TO MY SON. I AM LOOKING FOR ASSISTANCE TO REACH OUT TO (B)(4) FOR THE REPLACEMENT OF THIS MEDICAL DEVICE. I HAVE SUPPORTING EMAILS FROM THIS COMPANY THAT STATES THAT THIS WAS SUPPOSED TO BE REPLACED. PLEASE REACH OUT TO ME IF YOU HAVE ANY QUESTIONS REGARDING THIS MEDICAL DEVICE RECALL. THANK YOU (B)(6). FDA SAFETY REPORT ID # (B)(4).