BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATEX-OHMEDA S/5 M-ESTPR MODULE

    MDR report key: 486719 · Received September 26, 2003

    Report

    Report Number
    9610105-2003-00010
    Event Type
    Malfunction
    Date Received
    September 26, 2003
    Date of Event
    August 21, 2003
    Report Date
    September 26, 2003
    Manufacturer
    INSTRUMENTARIUM CORP., DATEX-OHMEDA DIVISION
    Product Code
    BZQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN ONE HOSP THEY EXPERIENCED BURN MARKS ON TWO PTS AFTER SURGERY. THE BURN MARKS WERE UNDER THE ECG ELECTRODES. IN THE FIRST CASE, DIATHERMY WAS USED, BUT IN THE SECOND CASE, THEY DID NOT USE DIATHERMY. THE EQUIPMENT IN USE WAS S/5 ADU/AM, M-ESTPR..04. THE SAME EQUIPMENT HAS BEEN IN USE SEVERAL OPERATIONS AFTER THE INCIDENTS, AND HAS NOT CAUSED ANY MORE INJURIES. THE UNIT IS TESTED FOR ELECTRICAL SAFETY, AND SEEMS OK. THE CO HAS NOT BEEN INFORMED ABOUT THESE INCIDENTS BEFORE TODAY. THE INCIDENTS ARE REPORTED TO AUTHORITIES. THE CO IS SENDING A LOAN UNIT TO THE HOSP, AND HAS ASKED THEM TO SEND THE M-ESTPR MODULE TO IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 M-ESTPR MODULE D-O S/5 MULTIPARAMETER MODULE BZQ INSTRUMENTARIUM CORP., DATEX-OHMEDA DIVISION M-ESTPR *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other