BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSPORT 2/VISA PATIENT NET 1.03.08

    MDR report key: 382985 · Received March 20, 2002

    Report

    Report Number
    382985
    Event Type
    Death
    Date Received
    March 20, 2002
    Date of Event
    March 7, 2002
    Report Date
    March 19, 2002
    Manufacturer
    DATASCOPE CORP, PATIENT MONITORING DIVISION
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    NO ALARMS ALERTED ER STAFF AS TO CHANGE AND/OR DETERIORATION IN PT'S CONDITION. PT WAS BEING MONITORED ON SUSPECTED MEDICAL DEVICE. RN FOUND PT ASYSTOLIC. PT WAS UNABLE TO BE RESUSCITATED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 5/14/02: PLEASE NOTE THAT DATASCOPE IS THE MFR OF THE PASSPORT2 MONITOR, AND THE DISTRIBUTOR OF THE PATIENTNET CENTRAL STATION. DETAILS OF THE EVENT HAVE BEEN FORWARDED TO THE MFR OF THE PATIENTNET CENTRAL STATION: MED, GEMS-IT, FORMERLY VITALCOM. THE SITE ADVISED DATASCOPE THAT A PT HAD EXPIRED WHILE BEING MONITORED WITH A PASSPORT2 VITAL SIGNS MONITOR AND PATIENTNET CENTRAL STATION MONITORING SYSTEM. THE SITE WAS UNABLE TO PROVIDE ANY ADD'L INFO RELATED TO THE MONITOR SETTINGS AT THE TIME OF THE EVENT, OR ANY HISTORY INFO FROM THE PATIENTNET CENTRAL STATION MONITOR INVOLVED IN THE EVENT, AS THE PT WAS DISCHARGED IMMEDIATELY FOLLOWING THE EVENT IN ORDER TO ALLOW THE MONITOR TO BE USED WITH ANOTHER PT. FOR THIS REASON, THE CONFIGURATIONS AND SETTINGS OF THE MONITOR AT THE TIME OF THE EVENT CANNOT BE DETERMINED. DATASCOPE SERVICE PERFORMED A COMPLETE FUNCTIONAL EVALUATION OF PASSPORT 2 MONITOR. IT WAS FOUND TO BE OPERATING ACCORDING TO FACTORY SPECIFICATIONS. IN ADDITION, DATASCOPE SERVICE EVALUATED THE PATIENTNET SYSTEM, WHICH WAS ALSO FOUND TO BE OPERATING ACCORDING TO SPECIFICATIONS. DETAILS OF THAT EVALUATION WERE DISCUSSED WITH THE MFR OF THE PATIENTNET CENTRAL STATION: MED, GEMS-IT, FORMERLY VITALCOM. MFR WAS ADVISED BY THE CUSTOMER'S BIOMEDICAL SUPERVISOR ON APRIL 4TH AND AGAIN ON APRIL 25TH THAT DUE TO THE ONGOING INVESTIGATION OF THE INCIDENT BY THE SITE, NO ADD'L INFO RELATED TO THE INCIDENT IS AVAILABLE FROM THE SITE AT THIS TIME. THE DATE FIRM RECEIVED INFO ABOUT THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT. MARCH 7. 2002. THE PASSPORT 2 MONITOR AND THE PATIENTNET CENTRAL STATION REMAIN IN THE POSSESSION OF THE CUSTOMER. NO INFO RELATED TO AUTOPSY IS AVAILABLE TO DATASCOPE CORP. ALTHOUGH DATASCOPE DID NOT SUBMIT THE REFERENCED REPORT AND DID NOT THEREFORE DETERMINE THE REASON CODE SELECTED BY THE USER FACILITY, THEY BELIEVE THAT THERE IS NO INFO AVAILABLE WHICH REASONABLY SUGGESTS THAT THE PASSPORT2 MONITOR CAUSED OR CONTRIBUTED TO THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PASSPORT 2/VISA PATIENT NET 1.03.08 PHYSIOLOGIC MONITOR/SYSTEM MHX DATASCOPE CORP, PATIENT MONITORING DIVISION PASSPORT2, DS-5300W(DSCP) *

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death GENERAL INFUSION PUMP, 2002.