BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBL 5 LEAD, SNAP, SHLD, AAMI, CHEST RGD

    MDR report key: 3221587 · Received July 1, 2013

    Report

    Report Number
    1218950-2013-02752
    Event Type
    Malfunction
    Date Received
    July 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K061707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO CAPTURE V5 ON 12-LEAD. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297555 CBL 5 LEAD, SNAP, SHLD, AAMI, CHEST RGD MKJ PHILIPS MEDICAL SYSTEMS 989803176171 11/12

    Patients

    Seq Age Sex Outcome Treatment
    1