BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 4182332 · Received August 8, 2014

    Report

    Report Number
    1218950-2014-04757
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Report Date
    June 7, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PR#: (B)(4).

    Description of Event or Problem · 1

    THE HEARTSTART XL WAS RETURNED TO PHILIPS FOR REPAIR DUE TO A SUSPECTED FAILURE OF THE A CONNECTOR DURING ECG RESULTING IN ECG FAILING. THERE WAS PT INVOLVEMENT, BUT IT WAS REPORTED THAT HER WAS NO PT OR USER HARMED AS A RESULT OF THIS ISSUE. IT WAS REPORTED THAT THE ECG FAILED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466809 HEART START XL MKJ PHILIPS MEDICAL SYSTEMS M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1