BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 1873527 · Received October 14, 2010

    Report

    Report Number
    9610816-2010-00610
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Report Date
    September 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THERE WAS A VENTRICULAR TACHYCARDIA ALARM AND THE DR. DID NOT REMEMBER HEARING THE ALARM. NO PATIENT HARM WAS REPORTED. EXAMINATION OF THE ALARM LOGS SHOWED THAT THE ALARM IN QUESTION HAD BEEN SILENCED AT THE CENTRAL STATION. THERE WAS NO MALFUNCTION AND THE SILENCING WAS INTENDED. 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 IS REQUESTING ALARM LOGS TO CONFIRM IF ALARMS OCCURRED AND IF THEY WERE SILENCED OR PAUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP70 INTELLIVUE PATIENT MONITOR DSI PHILIPS MEDICAL SYSTEMS M8007A

    Patients

    Seq Age Sex Outcome Treatment
    1