BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL 7

    MDR report key: 6276311 · Received January 25, 2017

    Report

    Report Number
    2031172-2017-00112
    Event Type
    Malfunction
    Date Received
    January 25, 2017
    Date of Event
    January 5, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURING NARRATIVE: OTHER, ADDITIONAL MANUFACTURING NARRATIVE (IF OTHER): THE RETURNED DEVICE WAS EVALUATED. DURING EVALUATION THE UNIT WAS ABLE TO POWER ON, HOWEVER, THE RADICAL-7 DISPLAY SHUT DOWN WITHIN A FEW SECONDS (SCREEN BLANK) AND 10 BEEPS ARE HEARD. WITH THIS CONDITION, THE DEVICE WAS UNABLE TO OPERATE FOR MORE THAN A MINUTE. THE 10 BEEPS ALARM LOOPED CONTINUOUSLY UNTIL THE DEVICE WAS SHUT DOWN BY HOLDING THE POWER KEY FOR A FEW SECONDS. THE INSTRUMENT BOARD WAS FOUND TO BE DEFECTIVE DUE TO A FAILED U21 (CURRENT LIMITER IC) ON THE INSTRUMENT BOARD. THE INSTRUMENT BOARD WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED TO MASIMO FOR EVALUATION. WHEN THE INVESTIGATION IS COMPLETE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WILL NOT STAY ON FOR LONGER THAN A MINUTE ONCE IT REMOVED FROM THE DOCKING STATION EVEN WITH A NEW BATTERY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I BELIEVE THERE MAY HAVE BEEN AN AUDIBLE ALARM, BUT I'M NOT FOR SURE. MONITORING WAS NOT POSSIBLE AFTER DEVICE WAS REMOVED FROM THE DOCKING STATION". NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59607 RADICAL 7 OXIMETER DQA MASIMO - 40 PARKER 23785

    Patients

    Seq Age Sex Outcome Treatment
    1