BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2241457 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02307
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED UNABLE TO ACQUIRE LEAD V1. THERE WAS NO REPORTED ADVERSE PT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNABLE TO ACQUIRE LEAD V1. 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 - ANDOVER 989803147691 0D

    Patients

    Seq Age Sex Outcome Treatment
    1