BEUDAMED
    FDA Adverse Event Death Summary report: N

    PHYSIOLOGICAL MONITOR MOD.3000

    MDR report key: 84109 · Received February 7, 1995

    Report

    Report Number
    84109
    Event Type
    Death
    Date Received
    February 7, 1995
    Date of Event
    October 20, 1994
    Report Date
    November 3, 1994
    Manufacturer
    DATASCOPE CORP.
    Product Code
    MHX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INACCURATE INVASIVE BP READINGS ON CO DEVICE CONTRIBUTED TO TREATMENT OF HYPERTENSION WITH MULTIPLE ANTIHYPERTENSIVE DRUGS. ADMITTING DIAGNOSIS: POSS ANEURYSM EVENT OCCURRED IN RECOVERY ROOM FOLLOWING RESECTION OF CONFINED RUPTURED LEFT ILIAC ANEURYSM WITH AORTO BIFEMORAL GRAFT INSERTION. IN RESPONSE TO AN EVENT REPORTED WHERE INVASIVE PRESSURE READINGS WERE REPORTED TO BE ARTIFICIALLY HIGH, CO ENGINEERING PERFORMED AN INVESTIGATION SEEKING AN EXPLANATION FOR THE PROBABLE CAUSE. THE UNIT SUSPECTED OF CAUSING THE PROBLEM (SN 5484-HO) WAS A 3000 MONITOR SHIPPED IN SEPTEMBER OF 1990. CO'S PRODUCTION AND SERVICE RECORDS WERE RESEARCHED IN ORDER TO ESTABLISH THE UNIT'S REPAIR HISTORY. PRODUCTION RECORDS INDICATE THAT REWORK OCCURRED TO THE UNIT DURING THE PRODUCTION BUILD. THIS REWORK INCLUDED UPDATING THE DATASETTE SOFTWARE, REPLACING THE ECG BOARD AND INTERNAL ECG CABLE, ADDING STATIC PROTECTION ENHANCEMENTS TO THE TREND AND HOST PROCESSOR BOARDS, AND REPLACING A CRACKED CRT. CO SERVICE RECORDS LIST ONE SERVICE INSTALLATION IN SEPTEMBER OF 1990. NO OTHER SERVICE RECORDS EXIST BECAUSE THE HOSP UTILIZES THEIR OWN BIOMEDICAL STAFF FOR UNIT MAINTENANCE. THE HOSP'S BIOMEDICAL STAFF REPORTED THAT THE UNIT DISPLAYED A P1 PRESSURE OF 300/200 WHEN A 120/80 PRESSURE SIMULATOR WAS CONNECTED. HOWEVER, THE SECOND CHANNEL P2 DISPLAYED THE PROPER PRESSURE. THE HOSP REPLACED THE PRESSURE BOARD (0670-00-0255) AND THE PROBLEM REMAINED. IT WAS REPORTED THAT THEY PROCEEDED TO DISMANTLE THE UNIT SEARCHING IN THE AREA NEAR THE FRONT JACK AND SWITCH BOARD (0670-00-0367). WHEN THE UNIT WAS RE-ASSEMBLED, THE PROBLEM WENT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHYSIOLOGICAL MONITOR MOD.3000 Implant INVASIVE BP MONITOR MHX DATASCOPE CORP. 3000 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| L| R