BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1250836 · Received November 25, 2008

    Report

    Report Number
    1218950-2008-00654
    Event Type
    Malfunction
    Date Received
    November 25, 2008
    Report Date
    October 27, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHOWED ERROR 10003, WHEN THE UNIT WAS POWERED ON. THE CUSTOMER EVALUATED THE DEVICE AND REPORTED THAT HE REPLACED THE DATA CARD TO RESOLVE THIS FAILURE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT SHOWED ERROR 10003, WHEN THE UNIT WAS POWERED ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTSTREAM XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1