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

Catalog Number 8604700

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 11/07/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.H3 other text : on-going.

Event Description

It was reported that during use a ventilator failure occurred.No injury reported.

Manufacturer Narrative

The responsible dräger service engineer could confirm the reported issue during on-site checking and the entire motor assembly was replaced, consequently.Also the evaluation of the log file confirms an issue with the ventilator motor on the date of event.The log entries demonstrate that the supervisor function of the software forced a shutdown of automatic ventilation after detecting a stalled motor.This is a safety measure to prevent from mechanical damages to the ventilator unit.The user is alerted to the shutdown of automatic ventilation by a corresponding alarm; manual ventilation remains possible and monitoring is still functional.The motor was provided for investigation and was examined and tested in the laboratory whereby the reported failure could not be reproduced.Maybe a sporadic failure was present during the event which did not arise again during testing.As the symptom was confirmed during on-site inspection/ log analysis and was solved by replacement of the motor it can be concluded that the motor was root cause for the reported ventilator failure.It can be summarized that the device behaved as specified upon the detected deviation; no patient consequences have been reported.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that during use a ventilator failure occurred.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: 18309673
• MDR Text Key: 330273655
• Report Number: 9611500-2023-00465
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2006
• 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