BEUDAMED
    FDA Adverse Event Death Summary report: N

    MP70 INTELLIVUE PATIENT MONITOR

    MDR report key: 1883847 · Received October 22, 2010

    Report

    Report Number
    9610816-2010-00643
    Event Type
    Death
    Date Received
    October 22, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    DSI
    PMA / PMN Number
    K021300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THAT WHILE A PATIENT WAS CODING, THE MP70 MONITOR WENT INTO STANDBY THREE TIMES WITHOUT USER INTERACTION. CUSTOMER STATED, DID NOT CONTRIBUTE TO DEATH, HAD PORTABLE ZOLL DEFIB IN USE DURING CODE. BASED ON PRELIMINARY DATA, A 37 SECOND GAP IN WAVEFORM REVIEW OCCURRED PRIOR TO PATIENT CODE. THE LOGS HAVE BEEN COLLECTED AND ARE UNDER REVIEW BY A PHILIPS CLINICAL SPECIALIST. 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 WHILE A PATIENT WAS CODING, THE MP70 MONITOR WENT INTO STANDBY THREE TIMES.

    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 Death