BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VUELINK INTERFACE PLUG-IN MODULE

    MDR report key: 2030779 · Received March 22, 2011

    Report

    Report Number
    9610816-2011-00151
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Report Date
    March 10, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DQA
    PMA / PMN Number
    K923682
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE VENTILATOR ALARMS WERE NOT ALARMING AT THE CENTRAL STATION, BUT WERE INSTEAD SHOWN AS INOPS. NO PATIENT HARM WAS REPORTED. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING 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 THE VENTILATOR ALARMS WERE NOT ALARMING AT THE CENTRAL STATION. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VUELINK INTERFACE PLUG-IN MODULE DQA PHILIPS MEDICAL SYSTEMS M1032A

    Patients

    Seq Age Sex Outcome Treatment
    1