BEUDAMED
    FDA Adverse Event Other Summary report: N

    BABYLOG 8000

    MDR report key: 2171931 · Received August 23, 2006

    Report

    Report Number
    9611500-2006-00031
    Event Type
    Other
    Date Received
    August 23, 2006
    Date of Event
    June 19, 2006
    Report Date
    August 23, 2006
    Manufacturer
    DRAEGER MEDICAL AG & CO. KG
    Product Code
    CBK
    PMA / PMN Number
    K974176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR WAS FILED IN RESPONSE TO UF-REPORT # (B)(4). THE USER FACILITY REPORT DESCRIBED THE SPECIFIED BEHAVIOUR IN CASE OF A POWER LOSS. IN CASE OF POWER LOSS, AN AUDIBLE ALARM POWERED BY A 9V BATTERY WOULD BE GIVEN. BECAUSE THIS ALARM IS GIVEN BY AN INDEPENDENT BUZZER, THE ALARM TONE IS DIFFERENT FROM THE "NORMAL" ALARM TONE AND WAS DESCRIBED BY THE USER AS "SHRILL NOISE." ADDITIONALLY, THE EMERGENCY BREATHING VALVE WOULD REMAIN OPEN ALLOWING SPONTANEOUS BREATHING. AFTER THE REPORTED EVENT, THE DEVICE HAS BEEN INVESTIGATED BY A DRAEGER SERVICE TECHNICIAN. IT WAS NOT POSSIBLE TO REPRODUCE THE BEHAVIOUR. THE BABYLOG 8000 WAS USED ON A POWER STRIP TOGETHER WITH ADD'L EQUIPMENT. THE POWER SUPPLY OF THE DEVICE WAS EXCHANGED AS A PRECAUTION AND SENT BACK FOR INVESTIGATION TO THE MFR. THE POWER SUPPLY WAS TESTED BY THE MFR OF THE DEVICE AND WAS FORWARDED TO THE SUPPLIER OF THE POWER SUPPLY FOR FURTHER INSPECTION. NO DEVIATIONS WERE DETECTED, THE POWER SUPPLY WAS FUNCTIONING WITHIN SPECIFICATION. THE REPORTED BEHAVIOUR WAS PROVOKED BECAUSE THE DEVICE WAS NOT CORRECTLY PLUGGED. THIS WAS CONFIRMED BY AN ERROR CODE WHICH WAS THE RESULT OF LOOSEN CONTACT BEFORE THE POWER WAS INTERRUPTED. ACCORDING TO THE OPERATING INSTRUCTIONS OF THE BABYLOG 8000, THE DEVICE HAS TO BE PLUGGED INTO A WALL OUTLET.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BABYLOG 8000 VENTILATOR CONTINUOUS CBK DRAEGER MEDICAL AG & CO. KG NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK