BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX-EMS DEFIBRILLATOR

    MDR report key: 2250980 · Received August 31, 2011

    Report

    Report Number
    1218950-2011-02574
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Report Date
    August 3, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE FAILS TO RECOGNIZE THE BATTERY DUE TO BENT BATTERY PCA PINS. THERE WAS NO REPORT OF PT INVOLVEMENT. A PHILIPS FSE WENT TO THE CUSTOMER SITE AND VERIFIED THE FAILURE. REPLACEMENT OF THE BATTERY PCA RESOLVED THE FAILURE. THE UNIT PASSED ALL TESTING AND REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILS TO RECOGNIZE THE BATTERY DUE TO BENT BATTERY PCA PINS. 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