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

Catalog Number 8607300

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

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

Event Date 02/14/2023

Event Type  malfunction  

Event Description

It was reported that 'ventilator stopped when patient connected and pc vent mode selected'.No injury reported.

Manufacturer Narrative

For the investigation the provided logfile was analysed.The log entries indicate that the vacuum pressure, that is required to keep the ventilator diaphragm in place, was too low.The software monitors several parameters that are relevant for a safe automatic ventilation, amongst others the membrane pressure (internal diaphragm vacuum).The fabius reacted as specified for this situation - stopped the automatic ventilation and posted a corresponding ventilator fail alarm.In this case, fresh gas delivery (incl.Agent) remains available and the patient can be ventilated using the manual breathing bag.There are several plausible root causes for such an issue with the vacuum pressure.On site, the dispatched service technician was able to reproduce the too low negative pressure by turning the a-cone switch during ventilation.However, the exact root cause could not be finally determined because also after calibrating the vacuum pump, the issue with the vacuum pressure was not solved.Thus, an intermittent leakage at a hose, e.G.At the a-cone switch or at the apl bypass valve, or a problem with the vacuum pump itself could be the root cause.Therefore, it has been recommended to check the hoses and the a-cone switch again and, if the problem cannot be solved, to replace the vacuum pump.

• Brand Name: FABIUS MRI
• 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: 16562934
• MDR Text Key: 311707562
• Report Number: 9611500-2023-00100
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K072884
• 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
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2018
• 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