BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2910641 · Received December 4, 2012

    Report

    Report Number
    1218950-2012-03981
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Report Date
    November 12, 2012
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THE UNIT DOES NOT OPERATE ON AC POWER. NO PT INVOLVEMENT WAS REPORTED. A PHILIPS FSE EVALUATED THE DEVICE AND VERIFIED THE FAILURE. THE ISSUE WAS DIAGNOSED AS AN AC POWER SUPPLY FAILURE. THE AC POWER SUPPLY WAS REPLACED TO RESOLVE THE ISSUE. THE DEVICE REMAINS AT THE CUSTOMER SITE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT DOES NOT OPERATE ON AC POWER. NO PT INVOLVEMENT WAS REPORTED.

    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