BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 4740430 · Received April 27, 2015

    Report

    Report Number
    1218950-2015-02275
    Event Type
    Malfunction
    Date Received
    April 27, 2015
    Report Date
    March 31, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART XL DISPLAYS CONFIGURATION LOST AND THEN ERROR CODE 10004 SYSTEM FAILURE CYCLE UPON POWER ON.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART XL DISPLAYS CONFIGURATION LOST AND THEN ERROR CODE 10004 SYSTEM FAILURE CYCLE UPON POWER ON.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO PHILIPS HEALTHCARE THAT THE HEARTSTART XL DISPLAYS THE ERROR CODE 10004 SYS FAILURE CYCLE UPON POWER ON. THERE WAS NO REPORT OF PT INVOLVEMENT AND THERE WAS NO ADVERSE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275963 HEART START XL DEFIBRILLATOR MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1