BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3952253 · Received May 13, 2014

    Report

    Report Number
    1218950-2014-02749
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Report Date
    April 23, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K061707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PARAMEDIC

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ECG CABLE FAILURE WITH NO OTHER INFORMATION. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285662 CBL 5 LEAD, SNAP, SHID, AAMI, LIMB, RGD MKJ PHILIPS MEDICAL SYSTEMS 989803176161 8-2012

    Patients

    Seq Age Sex Outcome Treatment
    1