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

Catalog Number 8604700

Device Problems Device Reprocessing Problem (1091); Gas Output Problem (1266); Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2022

Event Type  malfunction  

Manufacturer Narrative

A dräger service technician tested the device after the reported event without any deviation to specification.The elctronic log file was downloaded and submitted for analyses.Based on the information stored therein the case in question could be reconstructed.The log entries indicate, that a combination of a fresh gas deficit with an improperly opening auxiliary air intake valve led to the oberved ventilator failure.During downward movement of the piston the device detected that a negative pressure has been built-up to a certain level which is an indication for a fresh gas deficit.Such freh gas deficit can be caused by an unsuitable freh gas setting and/ or leakages in the patient circuit.The log entries do not allow for a more detailed analysis regading the exact root cause.However the provide evidence that the last leak test was perforemed on june 14.8 days prior to the reported event.This is against the instructions for use which advise the user to perform a leak test on a daily basis.The fabius is designed to open an auxiliary air intake valve on top of the ventilator to compensate the fresh gas deficit with ambient air.According to the log the compenstation did not happen as expected which indicates the the movement of the auxiliary air intake valve was restricted.The negative pressure further increased and the fabius finally reacted as specified by temporarily stopping the piston movement and generating a ventialtor failure alarm.In such case ventilation will resume automatically once the pressure is within the accepted range.Against the background of the technician's test results, it can be concluded there was no persistant device failure.Based on all availeble information it is seen likely that humidity has led to sticking or delayed opening of the valve.Based on experience this is caused by insufficient reprocessing (in particular drying).Traces can hardly be determined afterwards as the humidity will likely evaporate quickly.The fabius reacted as specified for this scenario.The number of similar cases is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported during a case he unit displayed a ventilator failure.There was no patient injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 15144664
• MDR Text Key: 304193948
• Report Number: 9611500-2022-00187
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2022
• Initial Date FDA Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2006
• 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