MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS PLUS XL; ANESTHESIA UNIT

Catalog Number 8608555

Device Problems Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)

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

Event Date 09/15/2023

Event Type  malfunction  

Manufacturer Narrative

The dispatched dräger service engineer could not duplicate the reported error condition when checking the workstation on-site but review of the log file confirmed that the device had forced a safety shut-down of automatic ventilation a few days before due to an encoder check error of the motor position.Although the error condition was not present during testing anymore, it was decided to replace the entire ventilator unit including the position detection system as a precautionary measure.The device passed all consecutive tests and was returned to use with no further problems reported to date.An encoder check error means that the supervisor function of the software has detected a deviation between measured and expected/calculated ventilator piston position.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.As confirmed for the particular case, manual ventilation and the monitoring functions remain available to the full extent.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted; all parts that can be put in causal connection to the error condition have been replaced, an in-depth investigation was not considered necessary.

Event Description

A ventilator failure was reported during use.The issue did not lead to consequences for the patient.Remark: this case is reported belatedly.It was determined during screening of service reports that the case incorporates a reportable event.

• Brand Name: FABIUS PLUS XL
• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18967129
• MDR Text Key: 338762310
• Report Number: 9611500-2024-00128
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675377610
• UDI-Public: (01)04048675377610(11)200708(17)200929(93)8608555-29
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8608555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2020
• 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