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

Catalog Number 8607000

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

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

Event Date 11/18/2021

Event Type  malfunction  

Event Description

It was reported, that the device stopped while in use.After that, the device was turned back on and started working again, so the user used it until the end of the surgery.Alarms : apl failure, ventilator failure no injury reported.

Manufacturer Narrative

The investigation was just started.The results will be forwarded in a follow-up report.

Event Description

It was reported, that the device stopped while in use.After that, the device was turned back on and started working again, so the user used it until the end of the surgery.Alarms: apl failure and ventilator failure.No injury reported.

Manufacturer Narrative

Based on the analysis of the provided logfile the described problem could be confirmed.On the reported date of event the logfile shows the entries v040 "motor slow" and v041 "motor stalled", which indicates a non-functional motor.The device was manufactured in the year 2008.Wear and tear of the collector disc may have caused the speed fluctuations during motor rotation.These speed fluctuations will result in deviations between the intended piston hub and the real one and, the applied tidal volumes will not match the settings.To prevent from potentially hazardous output the device is designed to shut down automatic ventilation and to post a corresponding alarm to alert the user.Manual ventilation with the built-in breathing bag remains possible in this state.Dräger finally concludes that the device behaved as specified for the specific error condition; no patient consequences occurred.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.The motor was successfully replaced on site and no further problems were reported.

• Brand Name: FABIUS GS PREMIUM
• 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: 12948256
• MDR Text Key: 287113179
• Report Number: 9611500-2021-00491
• 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,Followup
• Report Date: 01/21/2022

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: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/07/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2008
• 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