Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT ALLEGING NOSE IRRITATION, RESPIRATORY TRACT IRRITATION, DIZZINESS, HEADACHE, HYPERSENSITIVITY, ASTHMA (NEW OR WORSENING),INFLAMMATORY RESPONSE, LUNG DISEASE, REDUCED CARDIOPULMONARY RESERVE, SCAR TISSUE ON LUNGS, FIBROSIS (ITF), HEART FAILURE DUE TO LUNG DAMAGE AND OTHER. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AFTER THE MULTIPLE ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.