DEVILBISS

Additional Manufacturer Narrative

THE DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR REPORTED THAT A CPAP UNIT, MODEL DV54UK-P SERIAL (B)(4), WITH HEATER MODEL DV5HH SERIAL (B)(4), AND SMARTLINK MODEL SV5M SERIAL (B)(4) WERE RETURNED BY THE PATIENT. THE (B)(4) DISTRIBUTOR INITIALLY REPORTED THAT PATIENT'S CPAP "BEGAN TO SMOKE IN THE NIGHT AND [SMOKE] CAME THROUGH THE MASK." HOWEVER, UPON FURTHER COMMUNICATION BETWEEN (B)(4) DISTRIBUTOR AND THE PATIENT, IT WAS DETERMINED THE UNIT STOPPED OPERATING ONCE THE SMOKE STARTED AND THE PATIENT HAD NO COMPLAINT OF INJURY OR HEALTH-RELATED ISSUES DUE TO THE INCIDENT. THE UNIT WAS RETURNED TO DEVILBISS HEALTHCARE AND AN ENGINEERING INSPECTION AND EVALUATION WAS PERFORMED. THE RESULTS OF THAT INVESTIGATION INDICATED THAT THE CPAP UNIT FAILURE WAS CAUSED BY A LIQUID SUBSTANCE ONTO/ INTO THE ELECTRONIC ASSEMBLY. THE UNIT WAS IN USE FOR ABOUT 12 MONTHS AND THE LIQUID SUBSTANCE ON THE ELECTRONIC ASSEMBLY WAS LIKELY CAUSED BY A SPILL WHEN IN USE.

Description of Event or Problem

DEVILBISS HEALTHCARE'S (B)(4) DISTRIBUTOR REPORTED A CPAP UNIT, MODEL DV54UK-P, MALFUNCTIONED AND "CAUSED MINOR RESPIRATORY IRRITATION TO THE PATIENT". PATIENT ARRIVED AT THE HOSPITAL WITH HIS CPAP UNIT BUT THERE WAS NO INDICATION OF THE PATIENT WAS ADMITTED TO THE HOSPITAL. THE (B)(6) DISTRIBUTOR STATED THE PATIENT REPORTED "THE CPAP UNIT HAD STOPPED FUNCTIONING AND SMOKE STARTED TO COME OUT THROUGH THE MASK. IT WAS AT THIS POINT THE CPAP DEVICE STOPPED WORKING".