BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2890567 · Received November 15, 2012

    Report

    Report Number
    1218950-2012-03812
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 24, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT PACER MENU DOES NOT SCROLL IN PACER MODE. THERE WAS NO REPORTED PT INVOLVEMENT. THE CUSTOMER CONFIRMED THE FAILURE AND CLARIFIED THE SYMPTOM AS HE WAS NOT ABLE TO ACTIVATE THE PACER CONTROLS ONCE PACING WAS TURNED ON. THE ISSUE WAS LOCALIZED TO THE PACER KEYPAD ASSEMBLY. THE PHILIPS RESPONSE CENTER PROVIDED THE CUSTOMER A PARTS ID FOR THE PACER KEYPAD ASSEMBLY. THE CUSTOMER HAS NOT CALLED BACK REGARDING THIS ISSUE. THIS WAS A MALFUNCTION OF THE PACER KEYPAD ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PACER MENU DOES NOT SCROLL IN PACER MODE. THERE WAS NO REPORTED PT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1