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

Catalog Number 8606000

Device Problem Insufficient Information (3190)

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

Event Date 05/22/2021

Event Type  malfunction  

Manufacturer Narrative

The device is not under a service contract; the hospital uses a third-party service provider for repair and maintenance of their fleet.Dräger was contacting the user facility to obtain further information.It was responded that the device is back in use without further problems after the biomedical department has removed a minor nonconformity.It was not disclosed of what nature the nonconformity was.From the fact that an apnea alarm was posted cannot be concluded if a malfunction occurred or not - this type of alarm will be generated when the flow monitoring does not sense a valid breath at the patient opening.This is not necessarily related to a ventilator malfunction - a causal connection to patient condition or to an obstruction in the breathing circuit set would be imaginable as well.Differentiation is not possible due to lack of information, a reliable conclusion in regard to the exact root cause can't be made.A ventilator failure due to technical reasons is seen unlikely but can however not be fully excluded and thus, this report is filed in abundance of caution.

Event Description

It was reported that the users observed that the tidal volumes during automatic ventilation turned down to zero and that the workstation posted an apnea alarm.The patient was then manually ventilated until a replacement device was available; no patient consequences have reportedly occurred.

Event Description

It was reported that the users observed that the tidal volumes during automatic ventilation turned down to zero and that the workstation posted an apnea alarm.The patient was then manually ventilated until a replacement device was available; no patient consequences have reportedly occurred.

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.

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.

Event Description

It was reported that the users observed that the tidal volumes during automatic ventilation turned down to zero and that the workstation posted an apnea alarm.The patient was then manually ventilated until a replacement device was available; no patient consequences have reportedly occurred.

• Brand Name: FABIUS TIRO
• 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: 12048421
• MDR Text Key: 261548921
• Report Number: 9611500-2021-00269
• 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,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2012
• 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