BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1894642 · Received November 5, 2010

    Report

    Report Number
    1218950-2010-02182
    Event Type
    Malfunction
    Date Received
    November 5, 2010
    Report Date
    October 9, 2010
    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). THERE WAS NO MALFUNCTION OF THE DEVICE. THIS WAS A USE ISSUE.

    Description of Event or Problem · 1

    THIS CUSTOMER REPORTED THAT THE USERS PERFORMED AN OPERATIONAL CHECK ON THE DEFIBRILLATOR WHILE IT WAS ATTACHED TO THE PT. THERE WAS NO NEGATIVE IMPACT TO THE INVOLVED PT.

    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