MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH JULIAN; ANESTHESIA WORKSTATION

Device Problem Connection Problem (2900)

Patient Problem Death (1802)

Event Date 12/21/2013

Event Type  Death  

Event Description

It was reported that the user tried to reconnect a neurologic trauma pt to the julian after a clinic-internal transport assisted by a transport ventilator.It was not possible to build-up sufficient pressure/volume for resuscitation of the pt.The pt died in the course of event.

Manufacturer Narrative

Device was inconspicuous in a complete test provided at the user facility in f/u of the event.The in-depth investigation has just started; results will be provided in a f/u report.

• Brand Name: JULIAN
• Type of Device: ANESTHESIA WORKSTATION
• Manufacturer (Section D): DRAEGER MEDICAL GMBH; moislinger allee 53-55; lubeck 2354 2; GM 23542
• Manufacturer Contact: frank clanzett ; moislinger allee 53-55; luebeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 3624460
• MDR Text Key: 17384834
• Report Number: 9611500-2014-00008
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K983635
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/1996
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death