BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BABYLOG 8000

    MDR report key: 7984229 · Received October 19, 2018

    Report

    Report Number
    9611500-2018-003334
    Event Type
    Malfunction
    Date Received
    October 19, 2018
    Date of Event
    September 20, 2018
    Report Date
    December 5, 2018
    Manufacturer
    DRÄGERWERK AG & CO. KGAA
    Product Code
    CBK
    PMA / PMN Number
    K974176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL REPORT WAS ACCIDENTALLY SUBMITTED USING AN INCORRECT MDR REPORT NO (9611500-2018-003334). THEREFORE, THE INITIAL REPORT REGARDING THIS MDR REPORT NO IS A DUPLICATE AND CAN BE DISREGARDED. THE REPORT WAS RESUBMITTED WITH THE SAME INFORMATION UNDER THE CORRECT MDR REPORT NO (9611500-2018-00334).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE FAILED DURING OPERATION AND A POWER FAILURE ALARM SOUNDED. THE UNIT EMITTED SMOKE AND A CHARRED ODOR. THE DEVICE WAS THEN REPLACED BY THE USER. NO PATIENT INJURY HAS BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED BABYLOG 8000 WAS MANUFACTURED IN DECEMBER 1990 AND THE FAULTY POWER SUPPLY (MANUFACTURED IN: 1990) WAS AVAILABLE FOR THE INVESTIGATION. THE TECHNICAL ANALYSIS CONFIRMED A MALFUNCTIONING POWER SUPPLY AND IDENTIFIED TWO OVERHEATED CAPACITORS AS THE CAUSE OF THE REPORTED PROBLEM. FURTHER DAMAGE WAS NOT DETECTED. THE DEVICE BEHAVED AS SPECIFIED FOR A LOSS OF POWER DUE TO A FAULTY POWER SUPPLY BY GENERATING AN ACOUSTIC POWER FAILURE ALARM AND OPENING THE EMERGENCY BREATHING VALVE TO ALLOW FOR SPONTANEOUS BREATHING. THE ELECTRONICS OF THE BABYLOG 8000 POWER SUPPLY ARE DEVELOPED ACCORDING TO THE REQUIREMENTS OF UNDERWRITER (B)(4), WHICH MINIMIZES THE RISK OF FIRE DUE TO SELF-EXTINGUISHING COMPONENTS. WITH THE EMERGENCY BREATHING VALVE ON THE FRONT AND THE POWER SUPPLY COOLING HOLES ON THE BACK OF THE DEVICE, IT IS UNLIKELY THAT THE PATIENT INHALES SMOKE THROUGH THE EMERGENCY BREATHING VALVE WHEN SPONTANEOUS BREATHING OCCURS. 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 FAILED DURING OPERATION AND A POWER FAILURE ALARM SOUNDED. THE UNIT EMITTED SMOKE AND A CHARRED ODOR. THE DEVICE WAS THEN REPLACED BY THE USER. NO PATIENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823567 BABYLOG 8000 VENTILATORS, INTENSIVE CARE, NEONATAL/PEDIATRIC CBK DRÄGERWERK AG & CO. KGAA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1