BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 1853708 · Received October 1, 2010

    Report

    Report Number
    1218950-2010-01812
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Report Date
    September 3, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K031187
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE DID NOT WORK. THERE WAS NO REPORTED PT INVOLVEMENT. PHILIPS EVALUATED THE DEVICE AND CONFIRMED THE FAILURE. THE DEVICE WAS REPAIRED BY REPLACEMENT OF THE DISPLAY ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE DID NOT WORK. THERE WAS NO REPORTED 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