BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MP80 INTELLIVUE PATIENT MONITOR

    MDR report key: 1914917 · Received November 29, 2010

    Report

    Report Number
    9610816-2010-00764
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    PMA / PMN Number
    K030038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT THE MONITOR SHUT DOWN COMPLETELY DURING A CODE, RESET ITSELF AFTER 5 TO 10 MINS, WHICH HAPPENED MORE THAN ONCE. THE MONITOR RESET ITSELF AFTER 5 TO 10 MINS. BASED ON THE INITIAL AVAILABLE INFO WE WILL CONSIDER THIS A REPORTABLE EVENT ONLY BECAUSE THERE WAS A PT CODE INVOLVING MONITORING WITH A PHILIPS DEVICE. THE DEVICE REBOOTING IS OBVIOUS TO ALL USERS AS THE BLANK DISPLAY LOOKS NOTHING LIKE NORMAL MONITORING AND ALSO THERE ARE AUDIBLE ALERTS UPON RESTART. A PHILIPS FIELD SERVICE ENGINEER (FSE) IS GATHERING DATA FOR REVIEW. 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 CUSTOMER REPORTED THAT THE MONITOR SHUT DOWN COMPLETELY DURING A CODE, RESET ITSELF AFTER 5 TO 10 MINS, WHICH HAPPENED MORE THAN ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MP80 INTELLIVUE PATIENT MONITOR MHX PHILIPS MEDICAL SYSTEMS M8008A

    Patients

    Seq Age Sex Outcome Treatment
    1