BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADICAL-7 HANDHELD

    MDR report key: 6806660 · Received August 21, 2017

    Report

    Report Number
    2031172-2017-00812
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 28, 2017
    Manufacturer
    MASIMO - 40 PARKER
    Product Code
    DQA
    PMA / PMN Number
    K140188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. UPON RECEIVING, THE DEVICE FAILED VISUAL INSPECTION DUE TO MINOR SCRATCHES ON THE SCREEN AND COSMETIC DEFECTS. THE DEVICE WAS ABLE TO POWER ON USING AC AND DC POWER. THE DEVICE WAS NOT ABLE TO OBTAINED ANY READINGS BECAUSE RIGHT AFTER CONNECTING A SENSOR FOR TESTING, THE UNIT WOULD SHOW THE ALARM LIMIT VISUALLY, BUT NO SOUND WAS HEARD AND WOULD GO INTO A 7 BEEPS ERROR; WHICH INDICATES SPEAKER ERROR. INTERNAL INSPECTION REVEALED THE BAD SPEAKER HAD AN OPEN RESISTANCE ACROSS THE POSITIVE AND NEGATIVE LEADS AS OPPOSED TO THE RATING OF 8 OHMS. THE SPEAKER WAS REPLACED AND THE UNIT FUNCTIONED AS DESIGNED. A SERVICE HISTORY RECORD REVIEW REVEALS THAT THIS UNIT WAS IN THE FIELD FOR OVER TWO (2) YEARS WITH NO PREVIOUS REPORTED ISSUES PRIOR TO THIS REPORTED EVENT.

    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

    CUSTOMER REPORTS RADICAL-7 DOES NOT ALARM. NO CONSEQUENCES OR IMPACT TO PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588798 RADICAL-7 HANDHELD OXIMETER DQA MASIMO - 40 PARKER 23785

    Patients

    Seq Age Sex Outcome Treatment
    1