BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1841455 · Received September 16, 2010

    Report

    Report Number
    1218950-2010-01625
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Report Date
    August 17, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS CUSTOMER REPORTED THAT THIS DEVICE HAD AN ECG FAILURE. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS, AND THE REPORTED SYMPTOM WAS VERIFIED. REPLACEMENT OF THE POWER PCA RESOLVED THE SYMPTOM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THIS DEVICE HAD AN ECG FAILURE. THERE WAS NO REPORT OF PT INVOLVEMENT.

    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