BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4437521 · Received January 16, 2015

    Report

    Report Number
    1218950-2015-00325
    Event Type
    Malfunction
    Date Received
    January 16, 2015
    Report Date
    December 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBERS#: 08-2013 X 5, 01-2014 X 2, 03-2012 X 2, 04-2012. (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CUSTOMER REPORTED THE (B)(4) ECG LEADSET HAS NO SIGNAL - FAILED OPS CHECK. NO PATIENT INCIDENT/INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41073 CBL 5 LEAD, SNAP, SHID, AAMI, LIMB, RGD MKJ PHILIPS MEDICAL SYSTEMS 989803176161 08-2013 X , 01-2014 X 2

    Patients

    Seq Age Sex Outcome Treatment
    1