BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VM1

    MDR report key: 4905226 · Received July 10, 2015

    Report

    Report Number
    1218950-2015-03458
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Report Date
    June 23, 2015
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K082280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DID NOT HAVE SOUND DURING AN INITIAL STARTUP. NO PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE DEVICE DID NOT HAVE SOUND UPON DELIVERY. THERE WAS NO REPORT OF A DEATH OR SERIOUS INJURY, NOR WAS THERE A REPORT OF ANY ADVERSE IMPACT TO ANY USER OR PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450373 VM1 PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS 863264

    Patients

    Seq Age Sex Outcome Treatment
    1