BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1163407 · Received September 10, 2008

    Report

    Report Number
    1218950-2008-00487
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Report Date
    August 11, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE DEVICE HAS BEEN RECEIVED BY PHILIPS FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ECG WAS NOT A STRAIGHT LINE WITH THE TEST LOAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1