BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2963014 · Received January 23, 2013

    Report

    Report Number
    1218950-2013-00250
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Report Date
    December 31, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE (AC POWER MODULE) FAILED TO CHARGE THE BATTERY. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THE CUSTOMER'S BIOMED EVALUATED THE DEVICE AND CONFIRMED THE REPORTED COMPLAINT. THE AC POWER MODULE WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE (AC POWER MODULE) FAILED TO CHARGE THE BATTERY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33082 HEARTSTART MRX MKJ PHILIPS MEDICAL SYSTEMS M3535A

    Patients

    Seq Age Sex Outcome Treatment
    1