BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2941757 · Received December 27, 2012

    Report

    Report Number
    1218950-2012-04259
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Report Date
    December 2, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE DEVICE IS SHOWING A RED X. A RED X INDICATES A FAILURE THAT COULD IMPACT THE DELIVERY OF THERAPY. NO PT INVOLVEMENT WAS REPORTED. THIS COMPLAINT IS STILL BEING INVESTIGATED. A F/U REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE IS SHOWING A RED X. A RED X INDICATES A FAILURE THAT COULD IMPACT THE DELIVERY OF THERAPY. NO PT INVOLVEMENT WAS REPORTED.

    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