BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2150322 · Received June 7, 2011

    Report

    Report Number
    1218950-2011-01590
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Report Date
    May 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE CHARGE BUTTON WAS NOT WORKING IN OPERATIONAL MODE ON THEIR LOANER UNIT. THERE WAS NO REPORTED PT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM COULD NOT BE REPRODUCED AND NO TROUBLE WAS FOUND WITH THE DEVICE. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION BUT CANNOT DETERMINE THE CAUSE BECAUSE THE SYMPTOM COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CHARGE BUTTON WAS NOT WORKING IN OPERATIONAL MODE ON THEIR LOANER UNIT. THERE WAS NO REPORTED PT INVOLVEMENT.

    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