BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3905145 · Received June 10, 2014

    Report

    Report Number
    1218950-2014-03294
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THERE WAS NOISE IN THE HEARTSTART XL ECG WAVEFORM. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338886 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1