BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2211233 · Received July 11, 2011

    Report

    Report Number
    1218950-2011-01967
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Report Date
    June 14, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE SYNC BUTTON WAS NOT WORKING INTERMITTENTLY. THE CUSTOMER SPOKE WITH PHILIPS TO LOCALIZE THE ISSUE TO THE PROCESSOR PCA. THE CUSTOMER REPLACED THE PROCESSOR PCA TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYNC BUTTON WAS NOT WORKING INTERMITTENTLY.

    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