BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS

    MDR report key: 15957219 · Received December 12, 2022

    Report

    Report Number
    9611500-2022-00328
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 22, 2022
    Report Date
    January 18, 2023
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION HAS STARTED. RESULTS WILL BE PROVIDED WITH A SEPARATE FOLLOW-UP-REPORT.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS SUBJECT TO AN ON-SITE EVALUATION PERFORMED BY A DRÄGER SERVICE ENGINEER. THERE WAS NO PERSISTING MALFUNCTION DETECTED WITH THE DEVICE. AS A PREVENTIVE MEASURE THE VENTILATOR MOTOR AND THE PCB VENTILATION AND GAS CONTROLLER WERE REPLACED. THE DEVICE WAS TESTED AFTERWARDS AND WAS RETURNED TO USE. LOG FILE EVALUATION PROVIDED BY THE MANUFACTURER CONFIRMS THE REPORTED OBSERVATION IN GENERAL. THE DEVICE FORCED A SHUT-DOWN OF AUTOMATIC VENTILATION DUE TO A BLOCKED VENTILATOR PISTON. THE LOG PROVIDES EVIDENCE THAT THE SURGICAL PROCEDURE RIGHT FROM THE START WAS SUFFERING FROM A FRESH GAS DEFICIT. SEVERAL ALARMS OF TYPE FG LOW OR LEAK, PINSP NOT REACHED AND APNOE WERE POSTED. IN THE FOLLOWING, NEGATIVE PRESSURE PEAKS WERE DETECTED WHICH LED TO A BLOCKADE OF THE VENTILATOR PISTON, FINALLY. THE DEVICE RESPONDED AS DESIGNED AND SHUT DOWN AUTOMATIC VENTILATION WHILE POSTING A CORRESPONDING VENT FAIL ALARM TO ALERT THE USER. IN SUCH CASE, THE USER CAN CONTINUE THE CASE WITH MANUAL VENTILATION. GAS DELIVERY (INC. AGENT) AS WELL AS MONITORING FUNCTIONS REMAIN AVAILABLE. THE NEGATIVE AIRWAY PRESSURES IN COMBINATION WITH THE FRESH GAS DEFICIT IS THE TYPICAL LOG ENTRY SIGNATURE FOR THE USAGE OF A BRONCHIAL SUCTION SYSTEM WHILE THE PATIENT REMAINED CONNECTED TO THE BREATHING SYSTEM. FINALLY, NO INFORMATION COULD BE PROVIDED IF A BRONCHIAL SUCTION INDEED WAS USED. BUT THE ASSUMPTION IS SUPPORTED BY THE FACT THAT NEITHER AFTER THE EVENT NOR DURING MANUFACTURER INVESTIGATION A RELATED TECHNICAL DEVIATION WAS DETECTED. THEREFORE, BASED ON ALL AVAILABLE INFORMATION THE REPORTED EVENT WAS CAUSED BY THE USE OF A SUCTION DURING AUTOMATIC VENTILATION. THE PRIMUS INSTRUCTIONS FOR USE CONTAIN A CORRESPONDING WARNING: "WARNING RISK OF PATIENT INJURY IF NOT USED CORRECTLY, THE SUCTION UNIT MAY INJURE THE PATIENT. PRIOR TO USE, DISCONNECT THE PATIENT FROM THE VENTILATOR, AND PAY SPECIAL ATTENTION TO THE INSTRUCTIONS FOR USE OF THE SUCTION UNIT." AS THE INVESTIGATION HAS NOT REVEALED ANY DEVICE FAILURE THIS CASE IS FINALLY CONSIDERED NOT REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED DURING USE. THERE WAS NO INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATOR FAILED DURING USE. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424912 PRIMUS ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown