BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAD-8

    MDR report key: 4352112 · Received December 10, 2014

    Report

    Report Number
    2031172-2014-00521
    Event Type
    Malfunction
    Date Received
    December 10, 2014
    Date of Event
    March 15, 2014
    Report Date
    November 10, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K092838
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT WAS NOT RETURNED TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SUBMITTED. NO PATIENT INCIDENT REPORTED. THIS IS A FOLLOW UP TO THE USER FACILITY REPORT SUBMITTED AND RECEIVED BY MASIMO. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED "OUR THEN 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 UNIT 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 FOR A DIFFERENT MFR UNTIL THE ISSUE WAS RESOLVED. AFTER MONTHS, WITH THE HELP OF THE LOCAL SALES REPRESENTATIVE, MASIMO FINALLY REPLACED THE BAD UNITS WITH NEW ONES. WE RECEIVED ON 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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797149 RAD-8 OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1