Description of Event or Problem · 1
OUR THEN (B)(6), HIGH ACUITY SON REQUIRES 24/7 VENTILATION AND PULSE OXIMETRY MONITORING. FOLLOWING A CHANGE TO A NEW DME COMPANY, WE RECEIVED A BRAND NEW MASIMO RAD8 PULSE OXIMETER. WE WENT THROUGH THIS AND SEVERAL UNITS THAT HAD BAD BATTERIES. THE BATTERIES LASTED LESS THAN 15 MINUTES ON A FULL, OVERNIGHT CHARGE. THE DEVICE WOULD SHUT OFF, WITHOUT WARNING, IF BATTERIES WERE DEPLETED. THIS WAS VERY PROBLEMATIC FOR US AS WE HAD TO CARE FOR OUR SON OVERNIGHT 3 NIGHTS A WEEK (NIGHTS WE DIDN'T HAVE NURSING COVERAGE). THE UNITS WERE SENT BACK TO MASIMO FOR SERVICE AND RETURNED 3 TIMES WITH THE PROBLEM UNRESOLVED. OUR DME PROVIDER INFORMED US THAT MASIMO CORPORATE WAS NOT ADDRESSING THE ISSUE AND WAS MAKING IT DIFFICULT TO OBTAIN WARRANTY SERVICE. WE DEMANDED (AND WERE PROVIDED) A PULSE OXIMETER FROM A DIFFERENT MFR UNTIL THE ISSUE WAS RESOLVED. AFTER 4 MONTHS, WITH THE HELP OF THE LOCAL SALES REPRESENTATIVE, MASIMO FINALLY REPLACED THE BAD UNITS WITH NEW ONES. WE RECEIVED ONE OF THE NEW UNITS AND HAVEN'T HAD AN ISSUE SINCE. WE ARE REPORTING THIS BECAUSE IT IS DANGEROUS TO RECEIVE FAULTY MONITORING EQUIPMENT, ESPECIALLY FOR A HIGH ACUITY CHILD LIKE OURS. WE EXPERIENCED OUTAGES ON TWO OCCASIONS, DURING THE DAY, UNEXPECTEDLY. LUCKILY IT WAS DURING THE DAY WHEN WE ARE WATCHING THE MONITORS CLOSELY. AT NIGHT, HOWEVER, WE ARE UNABLE TO MONITOR THE DEVICE UNLESS IT ALARMS AND WAKES HIS CAREGIVERS/PARENTS UP. IF IT FAILS WITHOUT WARNING (AS IN THIS CASE) WE MAY NOT NOTICE A PROBLEM UNTIL IT'S TOO LATE.