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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Tidal Volume Fluctuations (1634); Failure to Deliver (2338); Gas/Air Leak (2946)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that a ventilator failure message appeared during a case.There was no injury reported.

Event Description

It was reported that a ventilator failure message appeared during a case.There was no injury reported.

Manufacturer Narrative

It was reported that a ventilator failure occurred during the case in question.Based on the log analysis this could not be comprehended.Only the entry "ex valve leak" was registered in the log.This event is logged when the device measures an expiratory flow of more than 15ml during the inspiration (and this vt is greater than 10% of vt flow during expiration).Automatic ventilation is continued in this case.After the case in question the doctor has found a disconnected pressure hose to the cosy (compact breathing system).Unfortunately, as no further information was provided it could not be determined which hose indeed was affected.The device was tested by a service technician on-site without finding any deviations from specification.The unit was returned to use without further problems reported.The causes of a "ex valve leak" entry are manifold.Based on the given information it is conceivable that a disconnected hose of the peep valve was causal.It can be concluded that the device has reacted as specified upon a detected deviation by posting a corresponding alarm.As the reported ventilator failure could not be confirmed the case is classified as non-serious incident.If investigation results were known before, the case would not have been rated reportable.

• 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: 15803894
• MDR Text Key: 303732503
• Report Number: 9611500-2022-00310
• 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: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2022
• 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
• Date Manufacturer Received: 12/16/2022
• 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