BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2113626 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01445
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 26, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 THERAPY PORT WAS NOT LATCHING SECURELY. THERE WAS NO REPORT OF PT IMPACT OR INVOLVEMENT. THE CUSTOMER LOCALIZED THE ISSUE TO THE THERAPY PORT CONNECTOR. BASED ON THE CUSTOMER'S REPORT, WE ARE CONSIDERING THIS A MALFUNCTION OF THE THERAPY PORT CONNECTOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE THERAPY PORT WAS NOT LATCHING SECURELY.

    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