BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTREAM XL

    MDR report key: 1193489 · Received October 8, 2008

    Report

    Report Number
    1218950-2008-00541
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THE DEFIB TEST WAS FAILING ON THIS UNIT. THE UNIT WOULD REPORT "ATTACH CABLE". THE CUSTOMER REPORTED THAT HE RESOLVED THIS ISSUE BY REPLACING THE THERAPY PORT CONNECTOR. PHILIPS DID NOT PERFORM THE REPAIR ON THIS UNIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEFIB TEST WAS FAILING ON THIS UNIT. THE UNIT WOULD REPORT "ATTACH CABLE".

    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