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

Catalog Number 8607000

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

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

Event Date 12/21/2021

Event Type  malfunction  

Manufacturer Narrative

The user facility did not involve the local dräger (b)(4) organization in examination of the device and consecutive remedies.The only additional information which was provided is that the device was inspected by a third-party service provider and that an issue with the vacuum pump has occurred.The exact nature of the error condition is unknown.Dräger concludes the following: the auxiliary vacuum pressure is needed to operate the valves which control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.If the vacuum pump cannot build-up the necessary pressure the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm.A reliable conclusion about the root cause for the event is not possible due to lack of information.However based on experience and in reflection of the fact that the device was in operation for three years only, the issue may simply be related to an occluded inlet filter of the vacuum pump.It is recommended by dräger to check the workstation in regular intervals; inspection of the inlet filter and replacement based upon visual appearance are part of the service and maintenance procedure.Dräger has no evidence that this was consequently done in the particular case.

Event Description

It was reported that a ventilator failure occurred during an anesthetic procedure.The device was replaced in a controlled maneuver; no patient consequences have occurred.

Manufacturer Narrative

The user facility did not involve the local dräger (b)(4) organization in examination of the device and consecutive remedies.The only additional information which was provided is that the device was inspected by a third-party service provider and that an issue with the vacuum pump has occurred.The exact nature of the error condition is unknown.Dräger concludes the following: the auxiliary vacuum pressure is needed to operate the valves which control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.If the vacuum pump cannot build-up the necessary pressure the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm.A reliable conclusion about the root cause for the event is not possible due to lack of information.However based on experience and in reflection of the fact that the device was in operation for three years only, the issue may simply be related to an occluded inlet filter of the vacuum pump.It is recommended by dräger to check the workstation in regular intervals; inspection of the inlet filter and replacement based upon visual appearance are part of the service and maintenance procedure.Dräger has no evidence that this was consequently done in the particular case.

Event Description

It was reported that a ventilator failure occurred during an anesthetic procedure.The device was replaced in a controlled maneuver; no patient consequences have occurred.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNIT
• 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: 13190530
• MDR Text Key: 285671041
• Report Number: 9611500-2022-00007
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)181116(17)190424(93)8607000-72
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: 3 YR
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2018
• 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