BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RAD-57

    MDR report key: 4662234 · Received March 27, 2015

    Report

    Report Number
    2031172-2015-00545
    Event Type
    Injury
    Date Received
    March 27, 2015
    Date of Event
    October 4, 2014
    Report Date
    March 12, 2015
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K080238
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. DURING EVAL THE DEVICE PASSED ALL VISUAL AND FUNCTIONAL TESTING. THE UNIT WAS FOUND TO VISUALLY AND AUDIBLY ALARM DURING ALARM CONDITIONS. THE UNIT WAS DETERMINED TO BE FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED "MASSIMO HAND HELD (RAD 57) DID NOT WORK DURING RESUSCITATION. ONGOING MASSIMO HAND HELD PULSE OXIMETER (RAD 57) SINCE 2012, CURE LETTER SENT (B) (6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205208 RAD-57 OXIMETER DQA MASIMO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other