BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 1812178 · Received August 19, 2010

    Report

    Report Number
    9610816-2010-00362
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 16, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PATIENT'S ECG AND SPO2 WAS BEING MONITORED AT THE CENTRAL STATION (CS), HOWEVER, THE BEDSIDE MONITOR WAS NOT COMMUNICATING WITH THE CS. BASED ON THE AVAILABLE INFORMATION, IT IS NOT KNOWN WHETHER THERE WAS AN INOP (NO CENTRAL MONITORING) SHOWING AT THE CENTRAL STATION. THE CUSTOMER DID STATE THAT MONITORING WAS PROVIDED AT THE BEDSIDE MONITOR. WE CONSIDER THE BEDSIDE MONITOR THE PRIMARY SOURCE OF MONITORING AND THERE WAS NO REPORT OF ANY FAILURE OF THE BEDSIDE MONITOR. THE CUSTOMER NOTED THAT THE CONNECTION OF THE MONITOR VIA THE NETWORK CABLE WAS DISCONNECTED AND RECONNECTED, WHICH THEN CAUSED THE DATA TO COME BACK TO THE CENTRAL STATION. PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION 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 CUSTOMER REPORTED THAT A PATIENT'S ECG AND SPO2 WAS BEING MONITORED AT THE CENTRAL STATION (CS), HOWEVER, THE BEDSIDE MONITOR WAS NOT COMMUNICATING WITH THE CS.

    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