MAUDE Adverse Event Report: DRAEGER MEDICAL GMBH FABIUS PLUS ANESTHESIA WORKSTATION

Device Problems Seal (432); Ring (943); False Reading From Device Non-Compliance (1228); Component Missing (2306)

Patient Problem Stroke/CVA (1770)

Event Date 07/11/2012

Event Type  Injury  

Event Description

It was reported that a patient was ventilated with the anaesthesia machine fabius plus and the physician recognized a big deviation between the co2 values measured by a nihon kohden patient monitor and the values given by the blood gas analysis. The physician believed in the values of the monitoring system but the patient state of health got worse. It was reported the patient received a brain infarction. An onsite investigation revealed that a missing seal ring at the carbon dioxide absorbance container caused bypass the co2 absorber.

Manufacturer Narrative

The instruction for use of the fabius plus requires an appropriate co2 monitoring. For that purpose the nihon kohden monitor (b)(4) was used. This monitor uses a so called auto zero function for the inspiration phase. To detect the increase of inspiratory co2 concentration this function is disadvantageous. Drager monitor systems do not use this functionality since many years. However, the monitor indicated an etco2 value of about 15mmhg which clearly indicates inadequate ventilation or metabolism of the patient. The clic adapter involved in the event was requested for investigation. Further information will be reported in the follow-up report.

• Brand Name: FABIUS PLUS
• 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; lubeck 23542 ; GM 23542 ; 518822868
• MDR Report Key: 2679619
• MDR Text Key: 2776741
• Report Number: 9611500-2012-00045
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (Y/N): N
• Reporter Country Code: JA
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 07/19/2012

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 07/20/2012
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: Yes
• Date Manufacturer Received: 07/13/2012
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 10/01/2011
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient TREATMENT DATA

Date Received: 07/20/2012 Patient Sequence Number: 1

Treatment

NIHON KOHDEN PATIENT MONITOR