BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2042817 · Received March 30, 2011

    Report

    Report Number
    1218950-2011-00843
    Event Type
    Malfunction
    Date Received
    March 30, 2011
    Report Date
    March 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE DISPLAYED ECG FAULT (ERROR). THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR NEGATIVE PATIENT IMPACT. THE PHILIPS REPRESENTATIVE CONFIRMED THE CONDITION REPORTED BY THE CUSTOMER AND ALSO CONFIRMED AN EXTENDED TEST PADS/PADDLES ECG FRONT END FAILURE ERROR CODE 90009. THE PHILIPS REPRESENTATIVE RESOLVED THE ISSUES BY REPLACING THE POWER PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DISPLAYED ECG FAULT (ERROR). THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR 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