BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 3962582 · Received June 26, 2014

    Report

    Report Number
    8010042-2014-00275
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K062793
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION SURROUNDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE REPORTED VENTILATOR UNIT WAS INVESTIGATED AT THE HOSPITAL BY OUR FIELD SERVICE ENGINEER. THE ON-SITE INVESTIGATION REVEALED THAT BY ADJUSTING THE ALARM SETTINGS WHICH WERE SET TOO HIGH, THE ALARMS WERE NO LONGER OCCURRING. THE UNIT PASSED THE PERFORMED PRE-USE CHECKS, SIMULATED USE TESTS, AND THE SAFETY CHECKS WITHOUT ANY DEVIATIONS OCCURRING. THE VENTILATOR DEVICE LOGS WERE RECEIVED FOR EVALUATION AND THE EVALUATION OF THE LOGS, FOR THE REPORTED DATE OF EVENT REVEALED A LEAKAGE IN THE PATIENT CIRCUIT, AND A POSSIBLE SETTINGS ISSUE CAUSING THE UNIT TO GENERATE THE REPORTED ALARMS. THE TEST LOGS SHOWED THAT THE UNIT PASSED THE PRE-USE CHECKS BOTH BEFORE, AND AFTER, THE EVENT. THE TECHNICAL LOGS DID NOT SHOW ANY TECHNICAL ALARMS INDICATING ANY MALFUNCTION OF THE REPORTED DEVICE. NO MORE COMPLAINTS REGARDING THIS VENTILATOR UNIT HAVE BEEN REPORTED SINCE THE CHANGE IN SETTINGS AND SUCCESSFUL TESTING HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE VENTILATOR THAT WAS VENTILATING IN THE PRESSURE CONTROL MODE OF VENTILATION WAS CONNECTED TO A PATIENT, INCREASED PEAK INSPIRATORY PRESSURE WAS NOTED WITH NO OR LITTLE PATIENT'S CHEST EXCURSION. THERE WAS LITTLE OR NO INSPIRATORY/EXPIRATORY VOLUMES. THE PATIENT WAS AT THE TIME INTUBATED WITH A 3.5 UNCUFFED ENDOTRACHEAL TUBE. THIS WAS CHANGED TO A 4.0 CUFFED ENDOTRACHEAL TUBE BUT WITH NO CHANGE. THE VENTILATOR WAS REPLACED AND THE PROBLEM WAS RESOLVED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372905 SERVO-I CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO