BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1960808 · Received December 17, 2010

    Report

    Report Number
    1218950-2010-02626
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Report Date
    November 21, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED A DEVICE ERROR/SERVICE REQUIRED MESSAGE FOR AN OPCHECK FAILURE. THERE WAS NO PT INVOLVEMENT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A DEVICE ERROR/SERVICE REQUIRED MESSAGE FOR AN OPCHECK FAILURE. THERE WAS NO PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1