BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SERVO-I

    MDR report key: 5123994 · Received October 2, 2015

    Report

    Report Number
    8010042-2015-01017
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 15, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K123149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OCTOBER 02, 2015 09:22 AM (GMT-4:00) ADDED BY (B)(6): FURTHER INFORMATION ABOUT THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE COMPLAINT HAS BEEN COMPLETED. IT IS BASED ON AN EVALUATION OF RECEIVED DEVICE LOGS AND AN INVESTIGATION OF THE RETURNED CONTROL PC BOARD. EVALUATION OF RECEIVED DEVICE LOGS CONFIRM SEVERAL OCCASIONS OF THE REPORTED TECHNICAL ERROR CODES ON THE DATE OF EVENT. LABORATORY TESTS DID NOT REPRODUCE THE ERROR CODES. SIMULATED USE TESTING OF THE RETURNED CONTROL PC BOARD IN A REFERENCE VENTILATOR FOR 6 DAYS WAS SUCCESSFUL AND 8 INTERSPERSED PRE-USE CHECKS ALSO SUCCEEDED. THE RETURNED CONTROL PC BOARD HAD VISIBLE TRACES OF DEPOSITS/CORROSION ON THE PC BOARD. TOGETHER WITH MOISTURE THIS MAY HAVE CAUSED TEMPORARY SHORT CIRCUITS ON THE PC BOARD. IF THE CONTROL PC BOARD ERROR OCCURS DURING STARTUP, BOTH AUDIBLE AND VISIBLE HIGH PRIORITY ALARMS WILL BE GENERATED AND VENTILATION CANNOT BE STARTED. IF THE UNDERLYING DEFECT APPEARS DURING VENTILATION, VENTILATION WILL STOP AND THE TECHNICAL ERROR WILL BE NOTIFIED TO THE USER BY A GENERATED HIGH PRIORITY ALARM AND THE CORRESPONDING TECHNICAL ERROR CODE. IF AN EXPIRATORY FLOW METER ERROR OCCURS, THE EXPIRATORY FLOW MEASURING IS AFFECTED BUT THIS WILL NOT AFFECTING ON-GOING VENTILATION. THE CONCLUSION IN THIS MATTER IS THAT CORROSION ON THE PC BOARD TOGETHER WITH MOISTURE CAUSED THE REPORTED ISSUE, BUT THIS COULD NOT BE REPRODUCED IN TESTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR GENERATED A TECHNICAL ERROR CODE INDICATING A FAILURE OF THE CONTROL PRINTED CIRCUIT BOARD. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654627 SERVO-I VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1