BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLOG 8000

    MDR report key: 7086059 · Received December 6, 2017

    Report

    Report Number
    9611500-2017-00370
    Event Type
    Malfunction
    Date Received
    December 6, 2017
    Report Date
    February 27, 2018
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K974176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE USER REPORTED ERROR CODE 004 WHICH INDICATES THAT THE MASTER CPU PCB OF THE BABYLOG 8000 HAD EXECUTED A RESTART (POTENTIALLY BECAUSE TO A COMPONENT MALFUNCTION). FURTHERMORE THE ERROR CODES 803 AND 810 HAVE BEEN REPORTED THAT CAN BE ATTRIBUTED TO DEVIATIONS REGARDING THE CONTROL PCB OF THE BABYLOG 8000. THEREFORE THE SUSPECTED PCB WAS REQUESTED FOR MANUFACTURER INVESTIGATION. DURING FUNCTIONAL TESTING OF THE RETURNED CONTROL PCB IN A LAB DEVICE, THE DEVICE GENERATED THE ERROR CODES 810, 803 AND 807 (ALL THREE ERROR CODES INDICATE A MALFUNCTION OF THE CONTROL PCB) AFTER POWER ON. THEREFORE NO VENTILATION WAS POSSIBLE. DURING AN ONGOING VENTILATION, THIS CONDITION WOULD BE ACCOMPANIED BY A CONTINUOUS AUDIBLE ALARM IN ORDER TO ALERT THE USER. THE DEVICE WOULD OPEN THE AIRWAY SYSTEM TO AMBIENT TO ALLOW SPONTANEOUS BREATHING. AN INVESTIGATION OF THE COMPONENTS OF THE AFFECTED CONTROL PCB REVEALED THAT TWO RESISTORS WERE OUT OF TOLERANCE AND THEREFORE CAUSED THE MALFUNCTION. THE DEVICE BEHAVED AS SPECIFIED TO THE DETECTED FAILURE. 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 · 1

    IT WAS REPORTED THAT THE DEVICE GENERATED ERROR CODES 803, 810, 004. NO INJURY REPORTED.

    Description of Event or Problem · 1

    REFER TO THE INITIAL-REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868189 BABYLOG 8000 VENTILATORS, INTENSIVE CARE, NEONATAL /PEDIATRIC CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1