BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX - EMS DEFIBRILLATOR

    MDR report key: 1972971 · Received January 20, 2011

    Report

    Report Number
    1218950-2011-00164
    Event Type
    Malfunction
    Date Received
    January 20, 2011
    Report Date
    December 22, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    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 UNIT FAILED TO RECOGNIZE THE BATTERIES. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED AT THE PHILIPS AND THE FAILURE WAS VERIFIED. UPON EVAL, IT WAS DETERMINED THAT A CABLE GOING TO THE BATTERY PCA WAS DISCONNECTED WHICH CAUSED THE UNIT NOT TO RECOGNIZE THE BATTERIES. THIS WAS AN INCOMPLETE ELECTRICAL CONNECTION THAT CAUSED THE UNIT NOT TO RECOGNIZE THE BATTERIES. THE CABLE WAS RECONNECTED WHICH RESOLVED THIS 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 FAILED TO RECOGNIZE THE BATTERIES. 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 M3536A

    Patients

    Seq Age Sex Outcome Treatment
    1