BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2200883 · Received June 30, 2011

    Report

    Report Number
    1218950-2011-01880
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 3, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD LOCK UP (STOP OPERATION) DURING THE USER INITIATED OPERATIONAL CHECK. THIS SYMPTOM MANIFESTED ONLY DURING USER INITIATED TESTING. THERE WAS NO PATIENT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE MALFUNCTION. THE MALFUNCTION WAS RESOLVED BY RELOADING THE SOFTWARE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD LOCK UP (STOP OPERATION) DURING THE USER INITIATED OPERATIONAL CHECK.

    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