BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBL 5 LEAD, SNAP, SHILD AAMI, LIBM RGD

    MDR report key: 3060987 · Received March 26, 2013

    Report

    Report Number
    1218950-2013-01014
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Report Date
    March 2, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K061707
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE 5 LEAD ECG CABLE DID NOT FUNCTION. THERE IS NO REPORTED PT INVOLVEMENT. THE COMPLAINT IS STILL UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE 5 LEAD ECG CABLE DID NOT FUNCTION. THERE IS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124621 CBL 5 LEAD, SNAP, SHILD AAMI, LIBM RGD MKJ PHILIPS MEDICAL SYSTEMS 989803176161

    Patients

    Seq Age Sex Outcome Treatment
    1