BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3071082 · Received April 8, 2013

    Report

    Report Number
    9610816-2013-00081
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    PHILIP MEDICAL SYSTEMS
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER STATED THAT THE INTELLIVUE MP5 MALFUNCTIONED WHILE IN USE. THE CUSTOMER STATED THAT THERE WAS A SPEAKER MALFUNCTION INOP, AND THAT THE SPEAKER DID NOT HAVE ANY SOUND. NO ADVERSE EVENT OR PATIENT IMPACT WAS REPORTED. A PHILIPS FIELD SERVICE ENGINEER (FSE) REPLACED THE DEFECTIVE PARTS (MP5 CBL SPEAKER ASSEMBLY) AND (MAINBOARD 4WIRE). AFTER REPLACING THE DEFECTIVE PARTS, THE DEVICE WAS WORKING AS EXPECTED. THE AVAILABLE INFORMATION FROM THIS REPORT DOES NOT SUPPORT THAT THE REPORTED ISSUE REPRESENTS A SYSTEMIC, DESIGN, OR LABELING PROBLEM. THIS COMPLAINT WILL BE INCLUDED IN PERIODIC TRENDING TO IDENTIFY ISSUES WARRANTING ADDITIONAL INVESTIGATION. THE CUSTOMER'S ISSUE WAS RESOLVED BY REPLACING THE DEFECTIVE SPEAKER, NO FINAL COMMUNICATION WAS REQUESTED AND NONE IS WARRANTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT THE INTELLIVUE MP5 MALFUNCTIONED WHILE IN USE. THE CUSTOMER STATED THAT THERE WAS A SPEAKER MALFUNCTION INOP, AND THAT THE SPEAKER DID NOT HAVE ANY SOUND. NO ADVERSE EVENT OR PATIENT IMPACT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144367 NONE MHX PHILIP MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1