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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Improper Flow or Infusion (2954); Pressure Problem (3012)

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

Event Date 08/21/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that the device cannot be used normally caused by a faulty front-end filter of the negative pressure pump.Reportedly the issue could be solved by the hospital engineer, no dräger service involved.It can be assumed that the inlet filter at the vacuum pump was occluded.After replacement of the filter the device was fully functional again.Dräger concludes the following: the auxiliary vacuum pressure is needed to operate the valves that control the ventilation cycles and to keep the ventilator diaphragm in place during piston movement.If the vacuum pressure is out of range the system reacts with a shutdown of automatic ventilation and generation of a corresponding alarm since a dislocated or wrinkled piston diaphragm may cause significant mechanical damages to the ventilator unit; impairment of valve actuation may cause insufficient ventilation.In this case the device allows manual ventilation including gas dosage; the monitoring functions remain unaffected.The workstation is subject to routine service and maintenance activities on a regular base.Dräger has defined service parts that shall be replaced in specified intervals and has put these together in service kits for the annual, 2 year, 3 year and 6 year maintenance.The bacteria filter for the vacuum pump is included in the service kit for the annual preventive parts exchange.H3 other text : device not available for investigation, 3rd party service.

Event Description

It was reported that the device cannot be used normally caused by a faulty front-end filter of the negative pressure pump.No injury reported.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18355651
• MDR Text Key: 331310885
• Report Number: 9611500-2023-00496
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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