BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASSY, CONSOLE, BV19600

    MDR report key: 3042874 · Received April 4, 2013

    Report

    Report Number
    3022472-2013-00070
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    VERATHON MEDICAL
    Product Code
    IYO
    PMA / PMN Number
    K082456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE UNIT WAS FOUND TO HAVE A FAULTY DATA COLLECTION MODULE (DCM) WHICH COULD HAVE CONTRIBUTED TO THE INACCURATE READING. THE VERATHON SERVICE REPRESENTATIVE REPLACED THE DCM, TESTED THE UNIT, AND IT NOW PERFORMS WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS GIVING LOW READINGS WHILE IN AORTA MODE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138448 ASSY, CONSOLE, BV19600 NONE IYO VERATHON MEDICAL 0570-0212

    Patients

    Seq Age Sex Outcome Treatment
    1