MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA JULIAN; ANESTHESIA UNITS

Catalog Number 8601110

Device Problems Loss of Power (1475); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided within a follow-up report.

Event Description

It was reported that during the procedure, while the patient was ventilated, a noise of gas depression was heard without apparent cause and that the respirator stopped abruptly.Following the restart of the device, the ventilation could resumed.No patient injury reported.

Manufacturer Narrative

The log file indicates that the self-monitoring function of the device had detected an error condition in the internal 5v supply line.Since this particular voltage is supplying the subsystems that control gas dosage and ventilation, the device is designed to perform a restart and switches to man/spont mode to allow manual ventilation.The alarm message vent inop and the actual operation mode is displayed on the screen.If the restart procedure is successful the julian resumes ventilation after 30 seconds with the last settings that have been identified as valid.According to the log file the particular error condition has already occurred on a few earlier occasion which would make parts exchange necessary.The device itself is almost 20 years old; end of service for this type of anesthesia workstation was proclaimed in 12/2013.Only limited spare parts are still available - the ones that would be necessary for the particular case are not.The entire device was scrapped.Dräger finally concludes that the device detected an ambiguous state that may have resulted in ventilation and/or gas dosage deviations and responded to this as designed - a restart was triggered to remove the error condition and the user was alerted to this condition by means of a corresponding alarm.Reportedly, the ventilation resumed with previous settings; there was no detail in the report which would reasonably suggest that patient consequences have occurred.A malfunction of a device sub-component after almost 20 years of operation can be considered well-acceptable.

Event Description

Please refer to initial mfr.Report #9611500-2018-00279.

• Brand Name: JULIAN
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 7831668
• MDR Text Key: 118875742
• Report Number: 9611500-2018-00279
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K983635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8601110
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1