BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET, SOFTWARE 4.0

    MDR report key: 1296175 · Received January 23, 2009

    Report

    Report Number
    MW5009729
    Event Type
    Injury
    Date Received
    January 23, 2009
    Date of Event
    January 20, 2009
    Report Date
    January 23, 2009
    Manufacturer
    MAQUET, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SOFTWARE UPGRADE - 4.0 - TO MAQUET SERVO-I VENTILATOR CAUSES THE VOLUME, TONE, AND LENGTH OF SOUND FROM CRITICAL ALARMS TO BE ALTERED AND GO UNRECOGNIZED. THE ALARM "ENHANCEMENT" CAUSES ALARM CONDITIONS TO GO UNRECOGNIZED BY CLINICIANS DUE TO THE SOFTNESS OF THE TONE, THE SHORTENED LENGTH OF TONE, AND CHANGE IN THE ALARM TONE ITSELF. IN ADDITION, NOT ALL MAQUET SERVO-I VENTILATORS, WHEN UPGRADED TO THE 4.0 SOFTWARE, CHANGE TO THE NEW ALARM "ENHANCEMENT", CAUSING ALIKE MAQUET SERVO-I VENTILATORS TO HAVE DIFFERENT ALARM SOUNDS FOR THE SAME ALARM CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAQUET, SOFTWARE 4.0 SERVO-I VENT CBK MAQUET, INC SERVO-I VENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability