BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1841410 · Received September 14, 2010

    Report

    Report Number
    1218950-2010-01584
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED GETTING NO PADS CONNECTION. THE PHILIPS RESPONSE CENTER STAFF LOCALIZED THE ISSUE WITH THE CUSTOMER TO A FAILED PADS CABLE. THE CUSTOMER WAS GIVEN THE ORDERING INFORMATION FOR THE REPLACEMENT CABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GETTING NO PADS CONNECTION.

    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