BEUDAMED
    FDA Adverse Event Other Summary report: N

    DATEX-OHMEDA S/5 ANESTHESIA MONITOR

    MDR report key: 488271 · Received October 3, 2003

    Report

    Report Number
    9610105-2003-00011
    Event Type
    Other
    Date Received
    October 3, 2003
    Date of Event
    August 5, 2003
    Report Date
    October 3, 2003
    Manufacturer
    INSTRUMENTARIUM CORP. DATEX-OHMEDA DIVISION
    Product Code
    BSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A REPEATED TECHNICAL FAULT WITH THE S/5 ANESTHESIA MONITOR HAS OCCURRED. THE K-ARK KEYBOARD COULD NO LONGER BE OPERATED. COM WHEEL OUT OF SERVICE. CONTROL PANEL KEYS OUT OF SERVICE. BREAKDOWN OF EKG AND SP02-WAVE ON SCREEN AND MISSING GAS MEASURING. THIS BREAKDOWN OF THE MONITOR WAS THE CAUSE FOR UNCLEAR CLINICAL PATHOLOGY AND PATIENT TREATMENT WITH VASOACTIVE SUBSTANCES, FORTUNATELY WITHOUT CONSEQUENCES FOR THE PATIENT. THE F-CU8 IS POPULATED AS FOLLOWS: B-CPU4, L-00A03, B-UPI4NET, B-DISP (2X), B-ARKFURTHER SYSTEM COMPONENTS: D-VMC15, D-LCC10A (SECONDARY SCREEN), K.ARKB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATEX-OHMEDA S/5 ANESTHESIA MONITOR DATEX-OHMEDA 8-MODULE FRAME BSZ INSTRUMENTARIUM CORP. DATEX-OHMEDA DIVISION F-CU8-22-07 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other