BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMUS

    MDR report key: 9621051 · Received January 23, 2020

    Report

    Report Number
    9611500-2020-00018
    Event Type
    Malfunction
    Date Received
    January 23, 2020
    Date of Event
    January 9, 2020
    Report Date
    February 19, 2020
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    BSZ
    PMA / PMN Number
    K042607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESPONSIBLE DRÄGER SERVICE ENGINEER COULD CONFIRM THE REPORTED ISSUE DURING ON-SITE CHECKING AND TRACE IT BACK TO THE VENTILATOR MOTOR. THE ENTIRE MOTOR ASSEMBLY WAS REPLACED, CONSEQUENTLY. ALSO THE EVALUATION OF THE LOG FILE CONFIRMS AN ISSUE WITH THE VENTILATOR (MOTOR) ON THE DATE OF EVENT. IN CASE THE PRIMUS SHUTS DOWN AUTOMATIC VENTILATION, THE DEVICE WILL GENERATE AN AUDIBLE ALARM AND A VISIBLE ALARM MESSAGE "VENTILATOR FAIL" WILL BE DISPLAYED. IN THIS CASE, AUTOMATIC VENTILATION IS NOT POSSIBLE. THE USER CAN SWITCH TO MANUAL VENTILATION AS DESCRIBED IN THE INSTRUCTIONS FOR USE. MONITORING IS STILL FUNCTIONAL. THE MOTOR ASM HAS BRUSHES, BALL BEARING, COMMUTATOR DISK AND A SPINDLE WHICH ARE AFFECTED FROM AGING CAUSED BY WEARING. THE KOLLMORGEN MOTOR ASM, THAT WAS INSTALLED IN THE OBJECTED DEVICE, HAS BEEN DESIGNED FOR A DURABILITY OF >10 YEARS (5 HRS/DAY, 5 DAYS/WEEK, 52 WEEKS/YEAR, 13000 HOURS). THE INVOLVED MOTOR IS APPROX. 11 YEARS OLD AND WITH THE 17855 HOURS LOGGED, THE DEVICE REACHED 137% OF THE ESTIMATED WORKING HOURS. THE REPLACEMENT OF THE AFFECTED MOTOR ASM BY THE DRÄGER SERVICE ENGINEER HAS ALREADY SOLVED THE PROBLEM, NO PATIENT CONSEQUENCES HAVE REPORTEDLY OCCURRED. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

    Description of Event or Problem · 0

    PLEASE REFER TO THE INITIAL-REPORT.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW UP-/FINAL-REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD A VENTILATOR FAILURE DURING USE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86315 PRIMUS ANESTHESIA UNITS BSZ DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1