BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10-LEAD ECG TRUNK CABLE, 12-PIN, 1.3M

    MDR report key: 2082716 · Received April 28, 2011

    Report

    Report Number
    1218950-2011-01178
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT 12 LEADS WERE WORKING INTERMITTENTLY. THERE WAS NO REPORTED ADVERSE PT IMPACT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED AND CONFIRMED THE PROBLEM. THE 12 LEAD ISSUE WAS RESOLVED BY REPLACING THE TRUNK CABLE. THE DEVICE PAST ALL PERFORMANCE ASSURANCE TESTS AND WAS RETURNED TO USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT 12 LEADS WERE WORKING INTERMITTENTLY. THERE WAS NO REPORTED ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10-LEAD ECG TRUNK CABLE, 12-PIN, 1.3M MKJ PHILIPS HEALTHCARE 989803147691

    Patients

    Seq Age Sex Outcome Treatment
    1