BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2150353 · Received June 7, 2011

    Report

    Report Number
    1218950-2011-01584
    Event Type
    Malfunction
    Date Received
    June 7, 2011
    Report Date
    May 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WERE BROKEN PINS ON THE THERAPY PORT. THERE WAS NO REPORT OF PATIENT IMPACT OR INVOLVEMENT. A PHILIPS FIELD SERVICE ENGINEER EVALUATED THE DEVICE AND CONFIRMED THE REPORTED SYMPTOM. THE THERAPY PORT AND THERAPY CABLE WERE REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WERE BROKEN PINS ON THE THERAPY PORT. THERE WAS NO REPORT OF PATIENT IMPACT OR 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