BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA S/5 TM CRITICAL CARE MONITOR

    MDR report key: 915182 · Received October 5, 2004

    Report

    Report Number
    9610105-2004-00012
    Event Type
    Malfunction
    Date Received
    October 5, 2004
    Date of Event
    May 25, 2004
    Report Date
    May 25, 2004
    Manufacturer
    DATEX-OHMEDA DIV./ INSTRUMENTARIUM CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATEX-OHMEDA HAS NOT RECEIVED ANY ALLEGATION OR CLAIM THAT THE REPORTED SITUATION CAUSED OR CONTRIBUTED DIRECTLY OR INDIRECTLY TO A DEATH OR SERIOUS INJURY. DURING PRODUCT DEVELOPMENT TEST PHASE WE HAVE FOUND PROBLEM THAT APPLIES ALSO WITH 12 LEAD MODULES AND L-ICU01(A)/L-ICU02(A)/ L-ICU03(A)/ L-ICU04(A) MONITOR SW DURING MONITORING STAND-BY. WE HAVE NOT RECEIVED SIMILAR CASES FROM THE CUSTOMERS. THE OBSERVED FAILURE WAS INVESTIGATED AND FAILURE IS S/5 CCM AND S/5 CCCM MONITOR SOFTWARE WAS FOUND. THE OBSERVED FAILURE IS CORRECTED IN S/5 CCM MONITOR SOFTWARE L-ICU03(A)..03 REV. 16.2 (RELEASED 10TH OF JUNE, 2004) AND IN S/5 CCCM MONITOR SOFTWARE L-CICU03(A)..01 REV. 16.2 (RELEASED 15TH OF JUNE, 2004). WE HAVE EVALUATED THE RISK AND WE WILL START A SYSTEMATIC FIELD CORRECTION ON THE DELIVERED UNITS. MARKETING BULLETIN MB CS HKI 04 012 (INFORMATION ABOUT SOFTWARE ISSUE FOUND IN MONITOR STAND-BY WITH 12-LEAD ECG IN S/5 CCM AND S/5 CCCM) AND ALSO TECHNICAL BULLETIN TB CS HKI 04 019 (ICU SOFTWARE FIELD ACTION- PRELIMINARY INFORMATION) WERE SENT TO THE DISTRIBUTORS. AN ADDENDUM ABOUT THIS ISSUE WILL BE SENT WITH EVERY 12-LEAD ECG MODULE (M-PRESTN) SHIPPED. DATEX-OHMEDA DOES NOT CONSIDER TAKING ANY FURTHER ACTIONS AT THIS POINT.

    Description of Event or Problem · 1

    DURING PRODUCT DEVELOPMENT TEST PHASE, WE HAVE FOUND A PROBLEM THAT APPLIES ALSO WITH 12 LEAD MODULES AND L-ICU01 (A)/ L-ICU02 (A)/ L-ICU03(A)/ L-ICU04(A) MONITOR SW DURING MONITORING STAND-BY. ECG WAVEFORM LABEL AND ACTUAL LEAD MISMATCH WILL BE CAUSED WITH THE FOLLOWING SEQUENCE: SELECT AN ECG LEAD DIFFERING FROM THAT STORED IN THE MODE. DISCONNECT THE ECG MODULE. PUT THE MONITOR INTO STANDBY FROM THE MENU. EXIT STANDBY BY RECONNECTING THE MODULE. NOW THE ACTUAL LEAD IS THE ONE PREVIOUSLY SELECTED, BUT LABEL ON THE SCREEN IS THAT STORED IN THE MODE. IN ADDITION THE ST CALCULATION IS INCORRECT. THE PROBLEM OCCURS WITH 12 LEAD MODULES AND L-ICU01(A)/ L-ICU02(A)/ L-ICU03(A)/ L-ICU04(A) MONITOR SW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 TM CRITICAL CARE MONITOR DATEX-OHMEDA CRITICAL CARE MONITOR MHX DATEX-OHMEDA DIV./ INSTRUMENTARIUM CORP. L-ICU01(A) *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other