[17889729]
Failure to replace recalled product. I am writing in reference to the recall of s8 flow generators by resmed. I believe the conduct of the recall has been ineffectual, unprofessional, and medically negligent. The inability of resmed and its contractors to replace this device has put me at greater risk for adverse event. Resmed will be held responsible for any adverse events until the matter is rectified. The facts of the situation are as follows: purchase of compact s8 cpap flow generator in 2004. In early spring, 2007, i receive mail from supplier, at home medical, that device may be recalled. No contact from resmed or contractors. On june 4, 2007, i call to confirm that the serial number is included in recall. I am told that a technician will call within 4 weeks. Delivery of replacement device scheduled for the following month. Technician does not show at appointed time. When contacted by telephone, she claims she "forgot. " she re-schedules; fails to show up again, and does not notify or re-schedule. On the same day, i call to complain. Customer service personnel and supervisors agree that technician acted "unprofessionally. " they promise that they will contact the local contractor and that both customer service and local contractor will call back. No calls received. No replacement re-scheduled. Fifteen days later, i call again. The poor service is acknowledged and apologized by the customer service representative and supervisors. They assure me that i will receive a call to re-schedule receipt of replacement within 24 hours. I have received no calls. The conduct of the recall is ineffectual in that the potentially defective device has not been replaced in approximately 5 months. From my perspective of 15 years in management within the pharmaceutical industry, i can say that this slow response has left pts at greater risk for an adverse event. Such a delay allows a longer time for a defective device to malfunction. The conduct of the support personnel has been unprofessional in that appointments and follow-up contacts have never been accomplished. Lastly, the conduct of the recall is medically negligent in that i have never been asked whether i require supplemental oxygen. The directions from resmed indicate "do not use supplemental oxygen with an affected device, until a replacement device has been provided. " should pts on supplemental oxygen discontinue its use for months? I urge the fda to review carefully the conduct of the recall of s8 generators by resmed.
Patient Sequence No: 1, Text Type: D, B5