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 EYE IRRITATION, SKIN IRRITATION, RESPIRATORY , DIZZINESS AND/OR , NAUSEA / VOMITING, INFLAMMATORY RESPONSE, KIDNEY DISEASE/TOXICITY, RESPIRATORY ISSUES (BREATHING PROBLEMS), KIDNEY DAMAGE, HEART FAILURE, HEART ATTACK, REACTIVE AIRWAY DISEASE (RAD), & ACUTE RESPIRATORY HEART ATTACK, REACTIVE AIRWAY DISEASE (RAD), & ACUTE RESPIRATORY DISTRESS SYSTEM (ARDS). THERE WAS REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURE FOR EVALUATION. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.