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 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

A dräger technician evaluated the device on-site; the reported issue of ventilator failure during the particular surgery was confirmed.Based on the findings it was decided to replace the ventilator motor unit; an additional issue with the power supply was corrected as well.The device passed all consecutive tests and could be returned to use without further problems reported to date.The ventilator failure was related to the aspect that the supervisor function detected a wrong motor position and forced a shut-down of automatic ventilation during the particular surgery.Such a shut-down is accompanied by the corresponding vent fail alarm; manual ventilation with the built-in breathing bag will be possible and, the monitoring functions remain unaffected.It can be concluded that replacement of the ventilator motor unit was an appropriate measure to put back the device into fully operable condition.The particular anesthesia device was in operation for 13 years now.Wear-and-tear related abrasion of the collector disc has led to intermittent contact loss to the carbon brushes which resulted in speed fluctuations.These speed fluctuations may cause potentially hazardous output or severe mechanical damages to the ventilator unit and thus, the device is designed to force a safety shut-down of automatic ventilation.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.Remark: during review of data for complaint closure was determined that the decision to report was filed in time but there was no initial mdr submitted within the applicable time frame, accidentally.

Event Description

It was reported that a vent failure was displayed during a case.There was no patient injury 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: 12966807
• MDR Text Key: 283505770
• Report Number: 9611500-2021-00497
• 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
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• 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
• Date Manufacturer Received: 10/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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