BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTELLIVUE MP5

    MDR report key: 2132488 · Received June 8, 2011

    Report

    Report Number
    9610816-2011-00318
    Event Type
    Injury
    Date Received
    June 8, 2011
    Report Date
    May 20, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K091395
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT A PT WENT INTO V-TACH WHILE CONNECTED TO A PHILIPS MP5 PT MONITOR. THE CUSTOMER STATED THAT THE PT'S PACEMAKER RATE INCREASED, WHICH CAUSED THE V-TACH EVENT. BASED ON THE AVAILABLE INFORMATION, THE CUSTOMER DISCONNECTED THE PT FROM THE BEDSIDE MONITOR AND 12-LEAD ECG MACHIN, AT WHICH POINT, THE PT'S PACING RATE AND HEART RATE DECREASED. THE CUSTOMER WAS ALSO ADVISED TO TURN OFF THE RESPIRATORY FEATURE ON THE DEICE FOR THIS PT. 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 PT WENT INTO V-TACH WHILE CONNECTED TO A PHILIPS MP5 PT MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIVUE MP5 MHX PHILIPS MEDICAL SYSTEMS M8105A (865024)

    Patients

    Seq Age Sex Outcome Treatment
    1