Description of Event or Problem · 0
PER MDR REPORT (B)(4) AS COMMUNICATED BY THE FDA TO BREAS MEDICAL, INC ON (B)(6)2 022: PT. RECEIVED VIVO 45 AFTER A SOFTWARE UPDATE AND EVERYTHING WAS WORKING AND THEN ONE DAY PATIENT WENT TO GET ON UNIT AND IT RED ERROR AND WOULD NOT ALLOW PATIENT TO USE VENTILATOR. MOBILE MEDICAL WAS NOT ABLE TO GET UNIT TO FUNCTION SO WE GAVE HIM A REPLACEMENT AND SENT UNIT BACK TO MANUFACTURER. THE REPORTER MOBILE MEDICAL WAS CONTACTED TO DETERMINE THE SERIAL NUMBER OF THE DEVICE IN QUESTION, AS WELL AS DETAILS OF THE EVENT. IT TURNED OUT THAT A COMPLAINT TICKET WAS ALREADY OPENED FOR THIS PARTICULAR EVENT AND IS RECORDED IN (B)(4). IT WAS DETERMINED FROM THE COMPLAINT INVESTIGATION THAT THE DEVICE STOPPED DURING DEVICE START UP PROCEDURES, CAUSING AN ALARM TO SOUND, AND SHOWING INTERNAL FUNCTION FAILURE ERROR 2 ON THE SCREEN. IT WAS CONFIRMED THAT THE PATIENT INVOLVED DID NOT SUFFER ANY INJURY OR HEALTH CONSEQUENCES. DEVICE LOG FILES WERE REVIEWED AND IT WAS CONFIRMED THAT THE DEVICE ALARMED WITH INTERNAL FUNCTION FAILURE 2 SEVERAL TIMES. THIS ERROR CODE SIGNALS A FAILURE OF THE MAIN PRESSURE SENSOR DURING STARTUP. THE DEVICE HAS TWO PRESSURE SENSORS, A MAIN AND A BACKUP, WHICH ARE CALIBRATED DURING STARTUP. THE CAUSE HAS BEEN TRACED TO IMPROPER TOLERANCE FOUND IN SENSORS FROM SOME BATCHES OF THIS COMPONENT, AND HAS BEEN ADDRESSED WITH CORRECTIVE ACTION TOGETHER WITH THE SUPPLIER. BASED ON INFORMATION RECEIVED, THE FAILURE IS NOT CONSIDERED LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY/DETERIORATION OF HEALTH IF THE EVENT WERE TO RE-OCCUR. THE DEVICE HAS PERFORMED AS DESIGNED AND INTENDED IF A MAIN PRESSURE SENSOR FUNCTIONAL FAILURE OCCURS, BY GIVING A HIGH PRIORITY AUDIBLE AND VISUAL ALARM. THERE HAS BEEN NO PATIENT HARM REPORTED AS A RESULT OF THE INCIDENT. RISK MITIGATION'S CURRENTLY IN PLACE ARE THEREFORE CONSIDERED EFFECTIVE TO REDUCE THE FINAL RISK LEVEL TO AFAP (AS FAR AS POSSIBLE).