BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2841410 · Received October 23, 2012

    Report

    Report Number
    1218950-2012-03556
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Report Date
    October 1, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WAS REBOOTING EVERY TEN SECONDS. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY PHILIPS. A DEFECTIVE INTERNAL MEMORY CARD WAS FOUND. THE INTERNAL MEMORY CARD WAS REPLACED THEN THE DEVICE WAS RETURNED TO THE CUSTOMER SITE AFTER PASSING ALL REQUIRED TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS REBOOTING EVERY TEN SECONDS. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1