BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-I

    MDR report key: 562424 · Received December 22, 2004

    Report

    Report Number
    562424
    Event Type
    Injury
    Date Received
    December 22, 2004
    Date of Event
    November 3, 2004
    Report Date
    December 20, 2004
    Manufacturer
    MAQUET, INC.
    Product Code
    CBK
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    THE VENTILATOR BATTERY FAILED TO COMMUNICATE TO PROVIDE "LIMITED BATTERY CAPACITY" ALARM 10 MINUTES BEFORE THE END OF LIFE OF THE BATTERY. ALSO WHEN ALARMS ACTIVATED AT "NO BATTERY CAPACITY", IT LASTED FOR "30S" INSTEAD OF A MINIMUM 3 MINUTES. OVERALL IT APPEARS TO BE SOFTWARE GLITCH IN READING BATTERY LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SERVO-I LIFE SUPPORT VENTILATOR CBK MAQUET, INC. SERVO-I *

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention SWITCHED TO ANOTHER VENTILATOR.