BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2200885 · Received June 30, 2011

    Report

    Report Number
    1218950-2011-01865
    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
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A SHOCK FAILURE MESSAGE WHEN TURNING ON THE DEVICE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT. THE DEVICE WAS EVALUATED AT PHILIPS AND THE REPORTED SYMPTOM WAS VERIFIED. REPLACEMENT OF THE THERAPY PCA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A SHOCK FAILURE MESSAGE WHEN TURNING ON THE DEVICE.

    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