BEUDAMED
    FDA Adverse Event Summary report: N

    HEART START XL

    MDR report key: 2240519 · Received August 26, 2011

    Report

    Report Number
    1218950-2011-02534
    Date Received
    August 26, 2011
    Report Date
    August 4, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DISPLAY ON THEIR UNIT DOESN'T WORK. THERE WAS NO REPORT OF PT INVOLVEMENT. THE UNIT WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER AND THE SYMPTOM WAS VERIFIED. THE ISSUE WAS RESOLVED BY REPLACING THE DISPLAY AND KEYSCAN PCA. BECAUSE MULTIPLE PARTS WERE REPLACED WE ARE UNABLE TO DETERMINE THE CAUSE OF THE MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY ON THEIR UNIT DOESN'T WORK. THERE WAS NO 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