BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX -EMS DEFIBRILLATOR

    MDR report key: 2043229 · Received March 15, 2011

    Report

    Report Number
    1218950-2011-00705
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT DEVICE INTERMITTENTLY DISPLAYED A RED X AND REBOOTED ITSELF FREQUENTLY. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE FAULT. THE INTERNAL MEMORY CARD WAS FOUND TO BE THE CAUSE OF THE FAILURE AND REPLACED. THE DEVICE PASSED ALL TESTS AND WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DEVICE INTERMITTENTLY DISPLAYED A RED X AND REBOOTED ITSELF FREQUENTLY. 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