BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VMI

    MDR report key: 4182118 · Received August 4, 2014

    Report

    Report Number
    1218950-2014-04510
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Report Date
    July 28, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE UNIT DOES NOT ALARM ON THE NURSE CALL INTERFACE. THERE WAS NO REPORT OF NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452818 VMI MHX PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1