BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILICHEK

    MDR report key: 2704348 · Received August 15, 2012

    Report

    Report Number
    3007056120-2012-00018
    Event Type
    Injury
    Date Received
    August 15, 2012
    Report Date
    July 16, 2012
    Manufacturer
    CHILDRENS MEDICAL VENTURES
    Product Code
    MQM
    PMA / PMN Number
    K010052
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE COMPLAINT ISSUE ALLEGED BY THE CUSTOMER WAS NOT ABLE TO BE CONFIRMED BECAUSE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    CHILDREN'S MEDICAL VENTURES (CHMV) RECEIVED A COMPLAINT REPORT FROM A HEALTH CARE PROFESSIONAL IN ASSOCIATION WITH A BILICHEK DEVICE. THIS INVESTIGATION HAS BEEN INITIATED DUE TO THE ALLEGATION OF A BILICHEK UNIT GIVING INCORRECT READINGS WHICH CONTRIBUTED TO THE HOSPITALIZATION OF 4 INFANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILICHEK MQM CHILDRENS MEDICAL VENTURES B800

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization