BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M

    MDR report key: 4231757 · Received October 14, 2014

    Report

    Report Number
    1218950-2014-06106
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K020531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE FAILURE OF THE M1669A ECG TRUNK CABLE. NO PT INCIDENT/INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650045 CBL 3 LEAD ECG TRUNK, AAMI/IEC 2.7M MHX PHILIPS MEDICAL SYSTEMS M1669A

    Patients

    Seq Age Sex Outcome Treatment
    1