BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 2113623 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01440
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 28, 2011
    Manufacturer
    PHILIPS MEDICAL
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE PADS, PACER, AND DEFIB TESTS DURING OPERATIONAL CHECK. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE PROBLEM WAS RESOLVED BY REPLACEMENT OF THE POWER PCA. AFTER PASSING ALL PERFORMANCE ASSURANCE TESTS THE DEVICE WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED THE PADS, PACER, AND DEFIB TESTS DURING OPS CHECK. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1