BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 2190119 · Received June 30, 2011

    Report

    Report Number
    1218950-2011-01885
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Report Date
    June 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE - ANDOVER
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THEY DISAGREE WITH A SHOCK ADVISORY DECISION IN THE AED MODE. THERE WAS NO REPORT OF NEGATIVE PT IMPACT. THIS COMPLAINT IS STILL BEING INVESTIGATED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY DISAGREE WITH A SHOCK ADVISORY DECISION IN THE AED MODE. THERE WAS NO REPORT OF NEGATIVE PT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE - ANDOVER M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1