BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIXTAL

    MDR report key: 2974817 · Received January 15, 2013

    Report

    Report Number
    1218950-2013-00438
    Event Type
    Other
    Date Received
    January 15, 2013
    Report Date
    January 22, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K893643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHILE THE DEVICE DISPLAY PROVIDES VISUAL INDICATORS OF ALARMS OCCURRING, THE DEVICE LABELING DOES NOT REPRESENT THAT DISPLAY DATA IS CONTINUOUSLY MONITORED BY STAFF. IN THE PRESENCE OF LIFE-THREATENING EVENTS WHEN THE USER IS UNAWARE THAT SOUND IS NOT AUDIBLE, AND NO STAFF MEMBER IS CONTINUOUSLY MONITORING THE DISPLAY, SERIOUS INJURY AND/OR DEATH CAN OCCUR. THE DEVICE WAS RETURNED FOR BENCH EVALUATION AND THE REPORTED PROBLEM WAS CONFIRMED. IT WAS FOUND THAT A WIRE HAD BROKEN OFF OF THE SPEAKER AND THE WIRE WAS RE-SOLDERED ONTO THE SPEAKER TO FIX THE PROBLEM. FUNCTIONAL, ACCURACY, ELECTRONIC AND SAFETY TESTING WAS PERFORMED AND ALL TESTING PASSED. THE DEVICE WAS RETURNED TO THE USER FACILITY. WE ARE NOT CONSIDERING THIS TO BE A MALFUNCTION OF THE DEVICE SINCE THE PROBLEM WAS CAUSED BY PHYSICAL DAMAGE OF THE DEVICE BY THE USER (DEVICE WAS DROPPED). THIS CAUSED THE WIRE TO BECOME BROKEN OFF OF THE SPEAKER. THERE WAS NO DEATH OR SERIOUS INJURY REPORTED AS A RESULT OF THIS PROBLEM AND PRODUCT HISTORY EVALUATION DOES NOT INDICATE THAT THIS IS AN INCREASING OR SYSTEMIC ISSUE. NO FURTHER ACTION OR INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THE DEVICE WAS NOT ALARMING AND THAT THE CASE WAS BROKEN. THERE WAS NO REPORTED PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23619 DIXTAL DQA PHILIPS MEDICAL SYSTEMS 515B

    Patients

    Seq Age Sex Outcome Treatment
    1