BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2253213 · Received August 3, 2011

    Report

    Report Number
    1218950-2011-02236
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Report Date
    July 5, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE MAINS LED IS NOT LIT. THERE WAS REPORT OF PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY PHILIPS FIELD SERVICE ENGINEER AND THE SYMPTOMS WERE VERIFIED. THE BEZEL ASSEMBLY WAS REPLACED TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE MAINS LED IS NOT LIT. THERE WAS REPORT OF PT 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