BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2220165 · Received August 11, 2011

    Report

    Report Number
    1218950-2011-02343
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Report Date
    July 15, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED UNABLE TO ACQUIRE V2 LEAD ECG. THERE WAS NO REPORTED ADVERSE PT IMPACT. THE LEAD SET WAS REPLACED TO RESOLVE THE ISSUE. THE LEAD SET WAS SCRAPPED AND NOT AVAILABLE FOR EVAL. WE WILL CONSIDER THIS A LEAD SET MALFUNCTION WHERE V2 LEAD ECG COULD NOT BE ACQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED UNABLE TO ACQUIRE V2 LEAD ECG. 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 OA

    Patients

    Seq Age Sex Outcome Treatment
    1