Description of Event or Problem · 0
THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO A VENTILATOR INOPERATIVE CONDITION OCCURRING IN CERTAIN BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING THE DEVICE SHUT OFF SUDDENLY AND THE SCREEN WAS BLANK UPON TURNING THE DEVICE BACK ON. THIS ISSUE HAS BEEN IDENTIFIED UNDER THE FSN 2023-CC-SRC-039. THERE WAS NO HARM OR INJURY REPORTED. THE VENTILATOR SUDDENLY TURNED OFF AT 10:00 ON APRIL 4, AND THE NON-INVASIVE VENTILATOR COULD WORK NORMALLY FOR A SHORT TIME AFTER RESTARTING THE NON-INVASIVE VENTILATOR, AND THE SCREEN WAS TURNED OFF SEVERAL TIMES FROM 10:00 TO10:30, SHOWING THE VENTILATOR NOT WORKING ALARM, AND THE NON-INVASIVE VENTILATOR WAS REPLACED AGAIN AFTER 10:40, DURING WHICH THE PATIENT'S VITAL SIGNS WERE TEMPORARILY STABLE, NO HARM OR INJURY HAS BEEN SUSTAINED AND THEREFORE FURTHER ANALYSIS OF CAUSE AND/OR CONTRIBUTION OF THE DEVICE TO A SERIOUS INJURY OR DEATH IS NOT APPLICABLE. DYSPNEA AND A DROP IN BLOOD SAMPLES IS THE REASON FOR THE HOSPITAL ADMISSION. THE DEVICE HAS YET TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE ALLEGED MALFUNCTION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.