BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2212721 · Received July 12, 2011

    Report

    Report Number
    1218950-2011-01963
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Report Date
    June 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER CONFIRMED IT WAS THE TRUNK CABLE THAT FAILED DURING TESTING, NOT THE DEVICE ITSELF. THE CUSTOMER REPLACED THE TRUNK CABLE AND RESOLVED THE ISSUE. THE CABLE WAS SCRAPPED AND NOT AVAILABLE FOR EVALUATION. WE WILL CONSIDER THIS A TRUNK CABLE FAILURE THAT CAUSED 12 LEADS ECG FALSE READINGS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED 12 LEADS ECG FALSE READINGS. 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

    Patients

    Seq Age Sex Outcome Treatment
    1