BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3242376 · Received June 19, 2013

    Report

    Report Number
    3242376
    Event Type
    Malfunction
    Date Received
    June 19, 2013
    Date of Event
    May 30, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MAQUET
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    VENTILATOR STARTED TO ALARM AND SHUT DOWN. VENTILATOR WAS READING TECHNICAL ERROR CODE 10003. PER MAQUET'S TECHNICIAN THE EXPIRATORY CHANNEL BOARD 1784 APPEARED TO HAVE FAILED WHICH IS UNUSUAL SINCE NO OTHER ERROR OF THIS TYPE HAD OCCURRED WITH VENTILATORS OF THIS MODEL. THERE IS A PRE-USE CHECK DONE BEFORE CONNECTING THE PATIENT AND THIS REDUCES A VARIETY OF SOFTWARE GLITCHES.======================MANUFACTURER RESPONSE FOR SERVO I VENTILATOR, MAQUET SWEDEN (PER SITE REPORTER).======================MAQUET'S TECHNICIAN WAS IN THE FACILITY AND REQUESTED TO KEEP SERVO I OUT OF SERVICE UNTIL MAQUET SWEDEN HAD EVALUATED THE LOGS. FROM MAQUET TECHNICIAN, BELIEVES EXPIRATORY CHANNEL BOARD 1784 APPEARED TO HAVE FAILED. COULD VERIFY PROBLEM IN LOGS BUT NOT ABLE TO DUPLICATE PROBLEM WITH VENT RUNNING 2 HOURS IN VENT MODE.THE PC 1771 CONTROL BOARD, WHICH HAD BEEN IDENTIFIED BY MAQUET AS THE CAUSE OF THE PROBLEM, HAS BEEN REPLACED. THE AFFECTED BOARD WILL BE ANALYZED BY MAQUET SWEDEN. A FINAL FUNCTIONAL VERIFICATION WITH THE NEWLY INSTALLED CONTROL BOARD - INCLUDING PRE-USE CHECK - WAS PERFORMED. THE NEWEST SOFTWARE 6.1.2 WAS LOADED AND THE ALARM SOUND DEFAULT WAS CHANGED TO ALTERNATIVE SOUND AS REQUESTED." WILL UPDATE YOU WITH ANY FURTHER INFORMATION FROM MAQUET SWEDEN.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PROVIDE ADEQUATE VENTILATION TO PATIENT.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278824 SERVO-I VENTILATOR CBK MAQUET * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR