BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1894623 · Received November 4, 2010

    Report

    Report Number
    1218950-2010-02162
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Report Date
    October 6, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE UNIT FAILED ONE TIME TO POWER ON WHEN ON AC POWER. A PHILIPS INVESTIGATOR SPOKE WITH THE CUSTOMER WHO VERIFIED THAT THIS HAPPENED ONLY ONCE, AND THERE HAS BEEN NO FURTHER ISSUE WITH THIS UNIT. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION. WE CAN NOT DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED SYMPTOM, AS THE CUSTOMER DID NOT SEND THE DEVICE TO PHILIPS FOR EVALUATION AND THE PROBLEM OCCURRED ONLY ONCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT FAILED ONE TIME TO POWER ON WHEN ON AC POWER.

    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