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 06/26/2021

Event Type  malfunction  

Event Description

It was reported there was a vent fail, the patient was bagged - there was no injury reported.

Manufacturer Narrative

Log file evaluation provided by the manufacturer revealed that the device stopped the ventilation intermittently because a significant negative pressure was measured during piston movement.This can be explained by the presence of a minimum of two superseding conditions: the breathing gas is circulating in a closed loop inside the system driven by the ventilator movement; in the volume balance the fresh gas flow of o2 added must be higher than the volume of patient o2 uptake and co2 absorption.Downward movement of the ventilator piston can cause a negative pressure when a fresh gas deficit occurs (e.G.Caused by patient activity, use of a bronchial suction system, too low fresh gas flow adjustment etc.).To suppress the effects of such negative pressure the ventilator is equipped with an emergency air intake valve on top of the ventilator lid; ambient air will be taken in to equalize the fresh gas deficit.If this emergency air intake valve is sticking the fresh gas deficit cannot be removed and the negative pressure may cross the threshold for next escalation level in the safety concept - the ventilation will intermittently stop until pressure went back above -5mbar again.This intermittent ventilation stop is accompanied by a corresponding "ventilator fail" alarm.Based on experience from earlier received similar complaints, not following the cleaning recommendations of the manufacturer can cause a sticking of the emergency air intake valve.This seems to be the most likely explanation for this particular case as well.

• 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: 13151801
• MDR Text Key: 286920517
• Report Number: 9611500-2022-00001
• 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: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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