MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS TIRO; ANESHESIA UNITS

Catalog Number 8606000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

For the investigation the provided logfile was analyzed.It was found that the auxiliary vacuum pressure dropped below the minimum value for safe operation.The auxiliary vacuum pressure is required to actuate the valves that control the ventilation and to keep the diaphragm of the ventilator piston in place to avoid wrinkling during piston movement.Insufficient vacuum pressure may result in serious damages to the ventilator unit and thus, the device is designed to shut down automatic ventilation upon occurrence.As reported, the ventilator shut-down was alerted to the user by means of a corresponding alarm.The user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.Potential root causes for the drop in vacuum pressure are manifold and are not necessarily related to device malfunctions - also an accidental disconnected actuator tube of the apl bypass valve can cause these symptoms.

Event Description

It was reported that an acoustical and visual "ventilator failure" alarm was posted during use on patient.No injury reported.

Event Description

It was reported that an acoustical and visual "ventilator failure" alarm was posted during use on patient.No injury reported.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

• Brand Name: FABIUS TIRO
• Type of Device: ANESHESIA 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: 12445260
• MDR Text Key: 271894705
• Report Number: 9611500-2021-00380
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K042419
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2011
• 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