BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2223226 · Received August 16, 2011

    Report

    Report Number
    1218950-2011-02402
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Report Date
    July 18, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DEVICE FAILED THE SHIFT TEST AND DISPLAYED A PADDLES FAILURE MESSAGE AND THE MESSAGE "SERVICE UNIT." THERE WAS NO PATIENT INVOLVEMENT. SUBSEQUENTLY THE BME REPORTED HAVING REPLACED THE PADDLE SET WITH A PADDLE SET FROM THEIR INVENTORY TO RESOLVE THIS ISSUE. WE ARE CONSIDERING THIS A PADDLE SET FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER'S BIOMEDICAL ENGINEER (BME) REPORTED THAT THE DEVICE FAILED THE SHIFT TEST AND DISPLAYED A PADDLES FAILURE MESSAGE AND THE MESSAGE "SERVICE UNIT." THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1