BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1953903 · Received December 15, 2010

    Report

    Report Number
    1218950-2010-02605
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Report Date
    November 17, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE INTERMITTENTLY DISPLAYED A RED X. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS FURTHER CLARIFIED TO BE AN INTERMITTENT HANG ON POWER UP. THE DEVICE WAS REPAIRED BY REPLACEMENT OF THE PROCESSOR PCA. THE DEVICE PASSED ALL TESTING AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE INTERMITTENTLY DISPLAYED A RED X.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX MKJ PHILIPS HEALTHCARE M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1