BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2091291 · Received April 20, 2011

    Report

    Report Number
    1218950-2011-01099
    Event Type
    Malfunction
    Date Received
    April 20, 2011
    Report Date
    March 24, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THEY HAD A DELAY IN OBTAINING A 12 LEAD ECG DURING A PATIENT EVENT. THE CUSTOMER EVENTUALLY WAS ABLE TO OBTAIN THE 12 LEAD. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THEY HAD A DELAY IN OBTAINING A 12 LEAD ECG DURING A PATIENT EVENT. THE CUSTOMER EVENTUALLY WAS ABLE TO OBTAIN THE 12 LEAD. THERE WAS NO NEGATIVE PATIENT IMPACT REPORTED.

    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 76 YR