BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2910644 · Received December 4, 2012

    Report

    Report Number
    1218950-2012-03978
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 8, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    N001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A KEY IS BROKEN. THERE WAS NO REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. THE SYMPTOM WAS CLARIFIED AS THE PACER KEY DID NOT WORK AND THE LOCAL FSE LOCALIZED THE PROBLEM TO THE PACER KEYPAD ASSEMBLY. THE PACER KEYPAD ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A KEY IS BROKEN. THERE WAS NO REPORT OF 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