BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3832377 · Received February 10, 2014

    Report

    Report Number
    8010042-2014-00019
    Event Type
    Malfunction
    Date Received
    February 10, 2014
    Date of Event
    May 30, 2013
    Report Date
    January 13, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL'S BIOMED REPLACED THE EXPIRATORY CHANNEL PRINTED CIRCUIT BOARD PC1784. THIS REPLACEMENT SOLVED THE PROBLEM AND THE VENTILATOR FUNCTIONED WITHOUT DEVIATION. OUR SERVICE ENGINEER WHO WAS DISPATCHED TO THE SITE AFTER RECEIPT OF THE MEDWATCH REPORT COLLECTED DEVICE LOGS BUT THE REPLACED PC 1784 HAD BEEN DISPOSED OF AND THEREFORE NOT AVAILABLE FOR INVESTIGATION. THE REPORTED SHUTDOWN COULD NOT BE CONFIRMED IN RECEIVED EVENT LOGS SINCE THE EVENT HAD OCCURRED IN (B)(6) 2013 AND THE LOGS WERE OVERWRITTEN. THE REPORTED TECHNICAL ERROR 35, TE35, INDICATES A COMMUNICATION FAILURE OR PC 1784 FAILURE DURING STARTUP. TE35 WAS CONFIRMED IN THE TECHNICAL LOG BUT SINCE NO PART IS AVAILABLE FOR INVESTIGATION IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE FAILURE. PER DESIGN TE35 OR A DEFECTIVE PC1784 WOULD NOT CAUSE A SHUTDOWN. (B)(4).

    Description of Event or Problem · 1

    MEDWATCH (B)(4) STATING THAT: "DURING PRE-USE TEST / SETUP THE MACHINE SHUT DOWN INADVERTENTLY. THERE WAS NO PT CONNECTED BUT IF PRE-TEST WOULD NOT HAVE BEEN DONE THE VENT COULD HAVE SHUT DOWN ON THE PT. THE MACHINE INDICATED AN ERROR 35." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87824 SERVO-I CBK MAQUET CRITICAL CARE AB NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA