BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 LEAD IEC ECG PATIENT CABLE

    MDR report key: 6177766 · Received December 15, 2016

    Report

    Report Number
    1218950-2016-07928
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    November 21, 2016
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    LDD
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LEADS ECG--UNABLE TO ACQUIRE LEADS ECG, INTERMITTENT ECG, OR OTHER LEADS ECG ISSUE/ERROR. A LEADS ECG RELATED ISSUE COULD PREVENT DEMAND MODE PACING OR DELAY THERAPY/TREATMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ECG READINGS ARE NOT AVAILABLE. THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826572 3 LEAD IEC ECG PATIENT CABLE ECG TRUNK CABLE LDD PHILIPS MEDICAL SYSTEMS M1510A 2C

    Patients

    Seq Age Sex Outcome Treatment
    1