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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)

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

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

The device was checked on-site by a dräger service engineer.The reported issue of shut-down of automatic ventilation during the concerned procedure could be confirmed upon the findings.The log contains entries which indicate that automatic ventilation was shut down due to an increase of the motor current exceeding the allowed threshold.Visual inspection of the ventilator unit revealed that a part had become loose which secures the piston diaphragm of the ventilator in place.The dislodged diaphragm has obviously hindered the piston in its movement whereby the current consumption of the motor increased to a level at which the supervisor function of the software forced a shutdown of ventilation to prevent from damages to the ventilator unit.Dräger finally concludes that the device responded as designed for such error condition; an appropriate alarm has been posted.Manual ventilation including gas dosage remains possible in this case.The exact root cause for the loosening of the part cannot be determined - the device was in operation for 15 years now which is already longer than the average expected life time.The status of preventive service and maintenance is not known - it cannot be excluded that the part was not properly installed after a previous repair ingress.

Event Description

It was reported to dräger that the anesthesia workstation passed the pre-use check but suddenly posted an alarm and failed to ventilate the patient automatically.As per report, the patient was connected to another device; no health consequences have occurred.

• 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: 16900682
• MDR Text Key: 314889998
• Report Number: 9611500-2023-00173
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/10/2023

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: 04/20/2023
• Initial Date FDA Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2008
• 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