BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 2042108 · Received March 30, 2011

    Report

    Report Number
    9610816-2011-00178
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THAT THERE WAS NO RED (HIGH PRIORITY) ALARM FROM EITHER THE BEDSIDE OR CENTRAL MONITORING WHEN AN ECG LEAD BECAME DISCONNECTED DURING ACTIVE PT MONITORING. BASED ON THE DESCRIPTION OF THE EVENT, THE CUSTOMER HAD TO GO THROUGH EMERGENT CARE WHICH IS CONSIDERED A SERIOUS INJURY. PLEASE NOTE THAT, WHEN A LEAD COMES OFF THE PT AND WHEN THAT LEAD IS NEEDED TO ACCOMPLISH THE ECG MONITORING, THERE WILL BE AN INOP ALERT (AUDIBLE AND VISUAL) AND NO ALARMING IS POSSIBLE DURING THE TECHNICAL INOP. THIS IS CLEARLY STATED IN THE DEVICE LABELING (IFU). PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFO REGARDING THIS INCIDENT 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 REPORTED DESCRIPTION OF THIS COMPLAINT NOTES THAT THERE WAS NO RED (HIGH PRIORITY) ALARM FROM EITHER THE BEDSIDE OR CENTRAL MONITOR WHEN AN ECG LEAD BECAME DISCONNECTED DURING ACTIVE PT MONITORING.

    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 Required Intervention