BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2031789 · Received March 21, 2011

    Report

    Report Number
    1218950-2011-00760
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT UNIT WILL NOT PASS THE ECG SELF TEST. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED AT PHILIPS. THE FAILURE WAS DETERMINED TO BE AN ERROR 90009 WHICH COULD IMPACT THE DELIVERY OF THERAPY. THE POWER PCA WAS REPLACED TO RESOLVE THE ISSUE. THE UNIT PASSED ALL POST SERVICING TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT UNIT WILL NOT PASS THE ECG SELF TEST.

    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