BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART MRX

    MDR report key: 2241487 · Received August 9, 2011

    Report

    Report Number
    1218950-2011-02315
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Report Date
    July 12, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    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 PACER EQUIPMENT MALFUNCTION MESSAGE AND A RED X. THE DEVICE WAS EVALUATED AT PHILIPS. THE SYMPTOM WAS VERIFIED. THE SYSTEM HUNG/LOCKED UP DURING THE OPERATIONAL CHECK, RESULTING IN THE CUSTOMERS REPORTED SYMPTOM. THE ISSUE WAS LOCALIZED TO THE PROCESSOR PCA. THE PROCESSOR PCA WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PACER EQUIPMENT MALFUNCTION MESSAGE AND A RED X.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1