BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBL 5 LEAD, SNAP, SLD, AAMI, LIMB, RGD

    MDR report key: 3905090 · Received June 10, 2014

    Report

    Report Number
    1218950-2014-03255
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 13, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K061707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED PHILIPS HEALTHCARE TO REPORT THAT THEY WERE UNABLE TO ACQUIRE A LEADS ECG WAVEFORM. THE RIGHT LIMB LEAD WAS NOT WORKING. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343205 CBL 5 LEAD, SNAP, SLD, AAMI, LIMB, RGD MKJ PHILIPS MEDICAL SYSTEMS 989803176161 6-2013

    Patients

    Seq Age Sex Outcome Treatment
    1