Description of Event or Problem · 0
PATIENT RECEIVED BRAND NEW VENTILATOR VIVO 45LS (BREAS) ITEM ID 230016, SERIAL NUMBER (B)(6) IN EXCHANGE FOR PREVIOUS VENTILATOR. HOME SERVICE WAS NOTIFIED BY PARENT THAT THE CLICK-IN BATTERIES TO THE NEW UNIT WERE NOT CHARGING PAST 31% DESPITE THE CLICK IN BATTERY DISPLAYING THE CORRECT "CHARGING" ICON ON THE FRONT OF THE CLICK-IN BATTERIES AS NORMAL. PARENT REPORTED THEY HAD BEEN PLACED OVERNIGHT AND THERE WERE NO ALARMS/ERROR MESSAGES RECEIVED THAT WOULD INDICATE OTHERWISE. DIRECTOR OF RESPIRATORY SERVICES REACHED OUT TO BREAS REPRESENTATIVE TO REPORT THE ISSUE. BREAS REPRESENTATIVE CONFIRMED THERE IS A KNOWN ISSUE WITH THE NEW FIRMWARE 5.1.9 FOR NEW UNITS THAT IT IS NOT RECOGNIZING THE CLIP IN BATTERIES. THE REPRESENTATIVE REPORTED THAT THE DEVICE MUST FIRST CHARGE TO 100% BATTERY INTERNALLY BEFORE PLACING CLICK-IN BATTERIES FOR CHARGING AS THE FIRMWARE IS NOT CONSISTENTLY RECOGNIZING THE CLICK-IN BATTERIES DUE TO THIS "GLITCH". AFTER REVIEWING THE USER MANUAL THERE IS NO NOTE OF THIS ISSUE EXISTING OR BEING IDENTIFIED BY THE MANUFACTURER. THE RESPIRATORY TEAM EXCHANGED THE PATIENT'S VENTILATOR AND BROUGHT SERIAL NUMBER (B)(6) INTO THE BIOMEDICAL TEAM TO TRIAL THE SUGGESTED FIX. THE FIX SUGGESTED BY THE REPRESENTATIVE WAS SUCCESSFUL. IN TOTAL, WE HAVE HAD 10 COMPLAINTS OF THIS ISSUE WITH BRAND NEW VENTILATORS AND NO FORMAL REPORTS FROM BREAS ON THEIR INTENT TO RESOLVE THE ISSUE DESPITE RISK OF ADVERSE EVENT BEING VERY HIGH WITH BATTERIES DISPLAYING THEY ARE CHARGING BUT NOT ACTUALLY TAKING A CHARGE FROM A BRAND-NEW UNIT. THE SERIAL NUMBERS FOR ALL AFFECTED BREAS VENTILATORS (ITEM ID 230016) WE HAVE RECEIVED SO FAR WITH THIS EXACT ISSUE FROM MULTIPLE PATIENTS ARE AS FOLLOWS: (B)(6). REFERENCE REPORTS: MW5172323, MW5172324, MW5172325, MW5172326, MW5172327, MW5172328, MW5172329, MW5172330 AND MW5172331. PT CODE: 4580. DEVICE CODES: 1085, 1012, 2506.