BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2113600 · Received May 24, 2011

    Report

    Report Number
    1218950-2011-01475
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Report Date
    April 29, 2011
    Manufacturer
    PHILIPS HEALTHCARE DUPLICATE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT CHARGE DURING TESTING. THERE WAS NO PT INVOLVEMENT. THE DEVICE WAS EVALUATED BY THE PHILIPS FIELD SERVICE ENGINEER AND IT WAS DETERMINED THAT THE SHOCK BUTTON ON THE PADDLE WAS FAULTY. REPLACEMENT OF THE PADDLE SET RESOLVED THE REPORTED SYMPTOM. THE DEVICE WAS RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WOULD NOT CHANGE DURING TESTING. 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 DUPLICATE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1