BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1961490 · Received January 10, 2011

    Report

    Report Number
    1218950-2011-00082
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Report Date
    December 13, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED INVALID INDICATIONS OF ATRIAL FIBRILLATION AND ATRIAL TACHYCARDIA. THERE WAS NO REPORT OF PT IMPACT. THE UNIT WAS SENT TO PHILIPS FOR EVAL. PHILIPS REPLACED THE LEADS ECG CONNECTOR TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INVALID INDICATIONS OF ATRIAL FIBRILLATION AND ATRIAL TACHYCARDIA. THERE WAS NO REPORT OF PT IMPACT.

    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