BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1214049 · Received October 23, 2008

    Report

    Report Number
    1218950-2008-00572
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Report Date
    September 23, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD UNEXPECTEDLY SHUT DOWN. THE CUSTOMER ORDERED A NEW BATTERY PCA. THE CUSTOMER REPLACED THE BATTERY PCA IN THE UNIT, AND THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE UNIT WOULD UNEXPECTEDLY SHUT DOWN.

    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