BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 2010147 · Received February 11, 2011

    Report

    Report Number
    9610816-2011-00085
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Report Date
    January 24, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP. NO PT WAS HARMED AS A RESULT OF THIS ISSUE. PHILIPS HAS NOT DETERMINED WHETHER OR NOT THE SPEAKER IS STILL AUDIBLE. THE VISUAL INOP WOULD BE OBVIOUS TO USERS. IN ABUNDANT CAUTION, WE WILL REPORT THIS AS A MALFUNCTION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A VISIBLE "SPEAKER MALFUNCTION" INOP. NO PT WAS HARMED AS A RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NONE MHX PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1