BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2150436 · Received June 8, 2011

    Report

    Report Number
    1218950-2011-01612
    Event Type
    Malfunction
    Date Received
    June 8, 2011
    Report Date
    May 13, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED A BLANK SCREEN. THERE WAS NO REPORT OF ADVERSE PT IMPACT. A PHILIPS FIELD SERVICE ENGINEER WENT ONSITE TO EVALUATE THE DEVICE. REPLACING BOTH THE CONTROL AND KEYSCAN PCAS RESOLVED THE REPORTED ISSUE. THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A BLANK SCREEN. THERE WAS NO REPORT OF ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1