BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1811312 · Received August 11, 2010

    Report

    Report Number
    1218950-2010-01299
    Event Type
    Malfunction
    Date Received
    August 11, 2010
    Report Date
    July 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS, AND THE REPORTED SYMPTOM WAS DUPLICATED. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TO POWER UP. THERE WAS NO REPORT OF 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