BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2170840 · Received June 22, 2011

    Report

    Report Number
    1218950-2011-01776
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Report Date
    May 26, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    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 UNIT HAD A RED X AND WAS SHUTTING DOWN. THERE WAS NO REPORT OF PT INVOLVEMENT. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED AT THE (B)(4) AND THE FAILURE WAS VERIFIED. REPLACING THE INTERNAL DATA CARD RESOLVED THE FAILURE. THE UNIT PASSED ALL POST-SERVICING TESTING AND WAS SHIPPED BACK TO THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT HAD A RED X AND WAS SHUTTING DOWN. THERE WAS NO REPORT OF PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTART MRX - EMS DEFIBRILLATOR MKJ PHILIPS HEALTHCARE - ANDOVER M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1