BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 LEAD ECG TRUNK AAMI/IEC 2M

    MDR report key: 3842504 · Received February 20, 2014

    Report

    Report Number
    9610816-2014-00039
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Report Date
    January 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSA
    PMA / PMN Number
    K020531
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FAILURE TO ACQUIRE PATIENT ECG SIGNALS VIA THE M1663A ECG TRUNK CABLE. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106651 10 LEAD ECG TRUNK AAMI/IEC 2M DSA PHILIPS MEDICAL SYSTEMS M1663A 2C

    Patients

    Seq Age Sex Outcome Treatment
    1