BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2102339 · Received May 18, 2011

    Report

    Report Number
    1218950-2011-01407
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Report Date
    April 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED AN INTERMITTENT FAILURE TO ACQUIRE PADS ECG (HEART RATE). THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT. THE UNIT WAS RETURNED TO PHILIPS AND EVALUATED. THE SYMPTOM COULD NOT BE DUPLICATED AND THE DEVICE PASSED ALL TESTING, THEREFORE, WE CANNOT DETERMINE THE CAUSE. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INTERMITTENT FAILURE TO ACQUIRE PADS ECG (HEART RATE). THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1