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 FOAM CAUSING HEALTH ISSUES. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. PIL TECH WAS ABLE TO CONFIRM THE DEVICE POWERS ON AND PROVIDES AIRFLOW. DURING REVIEW OF THE ERROR LOGS, PIL OBSERVED 1 INCIDENT OF E-193 (ERR_USB_HOST_NO_DEVICE) A CONTINUE ERROR. INTERNAL INVESTIGATION FOUND A DEEP CUT ACROSS THE TOP ENCLOSURE AND AN UNKNOWN DUST CONTAMINANT ON THE TOP ENCLOSURE, BOTTOM ENCLOSURE, BLOWER CAP, BLOWER, BLOWER IMPELLORS, BLOWER BOX AND BLOWER SEAL. A KERATIN-LIKE SUBSTANCE WAS OBSERVED ON THE BLOWER BOX OUTLET. ER-2243857(V01) ADDRESSES THE ISSUE OF KERATIN. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. PIL CONFIRMED NO PRESENCE OF DEGRADED SOUND ABATEMENT FOAM USING A FITT AND THE ASSOCIATED PROCEDURE ER 2245460 (V01). PIL IS UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS.