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

Catalog Number 8604700

Device Problems Disconnection (1171); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

The dispatched dräger service engineer confirmed the reported ventilator failure upon log file review.The recorded error codes indicated that the auxiliary vacuum pressure went out of range.The vacuum pump did not exhibit any deviation from specification during testing and, the vacuum pressure did not fully collapse.Facts from which could be concluded that the leak in the system was rather small.A loose valve actuator tube could be identified as the most likely root cause.The auxiliary vacuum pressure is needed to actuate the valves that control the ventilation and to keep the ventilator diaphragm in place during piston movement.With a vacuum pressure out of range the diaphragm may become dislodged which can cause severe mechanical damages to the ventilator unit.Furthermore, the control of the ventilation cycles may be disturbed significantly.Hence, the device is designed to shut down automatic ventilation and to post a corresponding alarm; manual ventilation with the built-in breathing bag remains possible.The vacuum pump has been replaced as a precautionary measure; the device was tested and returned to use.

Event Description

It was reported that the device exhibited a ventilator failure during use.The patient was connected to a replacement device; no health consequences have occurred.

Event Description

It was reported that the device exhibited a ventilator failure during use.The patient was connected to a replacement device; no health consequences have 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.

• 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: 13042144
• MDR Text Key: 284354160
• Report Number: 9611500-2021-00517
• 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,Followup
• Report Date: 06/06/2022

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: 12/06/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2007
• 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