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

Catalog Number 8606000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow up-report.

Event Description

It was reported that during anesthesia, the device did not ventilate.There was no patient injury reported.

Manufacturer Narrative

It was reported that the device ceased to ventilate during a surgical procedure.Reportedly the users introduced a replacement device and mentioned explicitly that no consequences to the patient have occurred.Dräger asked for further information but there was however none provided.Evaluation and assessment had to be done based on the initial description.The failure mode cannot be understood due to lack of information.In fact, it can even not be confirmed that a device problem has occurred - the presence of a large leakage in the patient circuit outside the device may also result in a significant decrease of gas flow at the patient opening and may lead to the perception that the device stopped to ventilate.The fabius tiro is equipped with integrated pressure-, volume- and o2-monitoring.A dedicated alarm will be generated if one measured value is out of adjusted alarm limits (insp pres not reach !!, apnea pressure !!!, apnea flow !!! etc.).Furthermore, patient gas monitoring is mandatory for anesthetic procedures allowing a constant overview of the gas exchange and efficacy of anesthesia.

Event Description

Please refer to initial mfr.Report # 9611500-2019-00394.

• Brand Name: FABIUS TIRO
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9374133
• MDR Text Key: 176856165
• Report Number: 9611500-2019-00394
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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: 8606000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1