BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2231238 · Received July 22, 2011

    Report

    Report Number
    1218950-2011-02100
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Report Date
    May 26, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE EQUIPMENT WAS BEEPING AND IT HAS A PASSWORD AND THE CLIENT IS NOT ABLE TO ACCESS IT. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM WAS CLARIFIED AS THE RFH (READY FOR USE) INDICATOR SHOWED A SOLID RED "X" AND A PERIODIC CHIRP, THE CHARGE BUTTON FAILED DURING THE OPCHECK. THE ISSUE WAS LOCALIZED TO A PROCESSOR PCA MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE EQUIPMENT WAS BEEPING AND IT HAS A PASSWORD AND THE CLIENT IS NOT ABLE TO ACCESS IT. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1