BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2140611 · Received June 16, 2011

    Report

    Report Number
    1218950-2011-01728
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Report Date
    May 20, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    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 REPEATING DEFIB FAILURE CYCLE POWER - ERROR CODE 01000 MESSAGES. THERE WAS NO REPORT OF PT INVOLVEMENT. THE LOCAL PHILIPS REPRESENTATIVE EVALUATED THE DEVICE, CONFIRMED THIS MALFUNCTION, AND RESOLVED THE PROBLEM BY REPLACING THE POWER PCA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED REPEATING DEFIB FAILURE CYCLE POWER - ERROR CODE 01000 MESSAGES. 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 M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1