Description of Event or Problem · 0
ON JUNE 21, 2023 DEVILBISS RECEIVED A COMPLAINT FROM AN END-USER REGARDING A DEVILBISS DV54 SERIES CPAP DEVICE, PURCHASED IN 2013 (5 YEARS BEYOND THE EXPECTED SERVICE LIFE AT THE TIME OF THE REPORT). THE END-USER STATED THE UNIT WAS OPERATING AS INTENDED, AND HE HAD NO COMPLAINTS OF ILLNESS OR INJURY, NOR DID HE SEEK MEDICAL ATTENTION ASSOCIATED WITH HIS USE OF THE DEVICE. DESPITE NO COMPLAINTS OF ILLNESS OR INJURY, OR ANY EVIDENCE OF PERFORMANCE ISSUES OR A DEVICE MALFUNCTION, THE END-USER STATED THAT BASED ON THE NEWS REGARDING THE PHILIPS CPAP PE-PUR FOAM ISSUES, HE DISASSEMBLED THE DEVICE TO EXAMINE THE FOAM AND OBSERVED SOME DEGRADATION OF THE FOAM. ON JUNE 27, 2023 DEVILBISS IDENTIFIED A RELATED MAUDE FILING (MW 5118808) FROM THE SAME END-USER REGARDING A DV5 CPAP DEVICE. THE COMPLAINT IN THE MAUDE STATES, "I AM A CPAP USER. I HAVE BOUGHT A DEVILBISS DV54D ONLINE FROM THE US. I AM A MALAYSIAN RESIDENT. DUE TO THE PHILIPS RECALL ON THE FOAM ISSUES, I HAVE OPENED MY CPAP MACHINE UP AND TO MY HORROR, THE FOAM FOR THE DEVILBISS HAVE DEGRADED AND THE FOAM PARTICLES AND SHEDDING IS ALL OVER THE FAN MOTOR AND THE CHAMBER. I HAVE NO RELATED SYMPTOMS BUT WORRY OF THE LONG TERMS RISK FOR BREATHING IN THIS FOAM MATERIAL. NO TEST PERFORMED. ONLY OPENED UP AND PERFORMED VISUAL INSPECTION OF THE SOUND ABATEMENT FOAM." BECAUSE THERE WAS NO MALFUNCTION OR INJURY ASSOCIATED WITH THE INITIAL COMPLAINT REPORTED TO DEVILBISS AND DUE TO THE AGE OF THE PRODUCT, IT WAS DETERMINED AN MDR REPORT TO FDA WAS NOT REQUIRED. DEVILBISS STILL BELIEVES THAT THIS EVENT IS NOT REPORTABLE, BUT IS FILING THIS REPORT IN RESPONSE TO THE VOLUNTARY MEDWATCH NUMBER MW5118808 TO PROVIDE ADDITIONAL INFORMATION. DEVILBISS HAS MONITORED COMPLAINTS RELATED TO DEVILBISS DV5 CPAP DEVICES SINCE THE LAUNCH OF THE PRODUCT LINE IN 2007, AND INCREASED DILIGENCE SINCE THE JUNE 2021 PUBLIC NOTIFICATION OF THE PHILIPS RECALL OF CPAP DEVICES USING PE-PUR FOAMS FOR SOUND ABATEMENT AS WELL AS CONDUCTED ADDITIONAL CONFIRMATORY TESTING. DEVILBISS HAS NOT DETECTED ANY PROBLEMS SIMILAR TO THE ONES IDENTIFIED BY PHILIPS SINCE THE DV5 SERIES WAS INTRODUCED IN 2007. THERE HAVE BEEN NO COMPLAINTS OF INJURY OR ILLNESS ASSOCIATED WITH THE USE OF THE DV5 SERIES CPAP IN THE 16 YEARS IT HAS BEEN ON THE MARKET. IF DEVILBISS UNCOVERS ANY FURTHER RELEVANT INFORMATION, UPDATES WILL BE PROVIDED.