BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2082013 · Received April 26, 2011

    Report

    Report Number
    1218950-2011-01123
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 29, 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 MRX FAILED DURING PT CARE. THE UNIT POWERED OFF BY ITSELF AND DISPLAYED A SYSTEM FAILURE PROMPT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MRX FAILED DURING PT CARE. THE UNIT POWERED OFF BY ITSELF AND DISPLAYED A SYSTEM FAILURE PROMPT.

    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 83 YR