BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2082702 · Received April 28, 2011

    Report

    Report Number
    1218950-2011-01185
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE SHOCK BUTTON TEST. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS BENCH EVALUATED THE DEVICE FOR THE CUSTOMER COMPLAINT AND CONFIRMED THE PROBLEM. THE REPAIR BENCH REPLACED THE THERAPY PCA TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE SHOCK BUTTON TEST. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX-EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1