THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, THEREFORE, RESMED IS UNABLE TO DETERMINE AT THIS TIME IF THE INCIDENT WAS CAUSED BY THE ALLEGED MALFUNCTION. RESMED IS IN COMMUNICATION WITH THE REPORTER TO OBTAIN ADDITIONAL INFORMATION REGARDING EVENT DETAILS AND HAS REQUESTED THE UNIT BE RETURNED SO THAT AN EXTENSIVE ENGINEERING INVESTIGATION CAN BE PERFORMED. ONCE THE DEVICE IS RETURNED AND THE INVESTIGATION IS COMPLETED, RESMED WILL PROVIDE A FOLLOW-UP REPORT WITH ADDITIONAL INFORMATION. RESMED REFERENCE #: (B)(4).
D
Patient 1
IT WAS REPORTED TO RESMED THAT AN APNEALINK HOME SLEEP TESTING DEVICE ALLEGEDLY MALFUNCTIONED CAUSING FIRST DEGREE BURNS TO THE USER'S ABDOMEN.
N
Patient 1
THE DEVICE WAS NOT RETURNED TO RESMED FOR INVESTIGATION. PICTURES OF THE DEVICE AND PATIENT BURNS WERE PROVIDED TO RESMED, THEREFORE, THE COMPLAINT COULD BE CONFIRMED. AN EXTENSIVE ENGINEERING INVESTIGATION WAS PERFORMED ON THE PICTURES. REVIEW OF THE PICTURES PROVIDED TO RESMED REVEALED THAT THE DEVICE WAS USED WITH BATTERIES WITH GREATER VOLTAGE THAN SPECIFIED IN THE RESMED CLINICAL MANUAL. BASED ON THE INFORMATION AVAILABLE, THE INVESTIGATION DETERMINED THAT THE REPORTED EVENT WAS MOST LIKELY DUE A SHORT CIRCUIT OF THE BATTERIES USED WITH THE DEVICE. THE APNEALINK DEVICE DOES NOT CONTAIN A BUILT IN POWER SOURCE. POWER REQUIREMENTS ARE DEFINED IN THE CLINICAL MANUAL. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. NOTE: DURING AN AUDIT OF THE COMPLAINT RECORDS, IT WAS FOUND THAT A FOLLOW-UP REPORT IS REQUIRED AS NEW INFORMATION IS AVAILABLE. THIS REPORT IS SUBMITTED TO ADDRESS THE REPORTABLE EVENT. RESMED REFERENCE#: (B)(4).