BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 3100003 · Received April 26, 2013

    Report

    Report Number
    1218950-2013-01486
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 3, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER (FSE). THE REPORTED SYMPTOM WAS CONFIRMED AND ISOLATED TO THE AC POWER ASSEMBLY. THE AC POWER ASSEMBLY WAS REPLACED. THE DEVICE THEN PASSED ALL REQUIRED TESTING AND REMAINS AT THE CUSTOMER SITE FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE WAS NOT POWERING UP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181832 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1