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

Catalog Number 8604700

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338); Detachment of Device or Device Component (2907)

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

Event Date 03/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation was started, the results will be provided in a follow-up report.

Event Description

It was reported during use that the unit displayed vent failure.The patient was bagged until the end of the case and there was no patient injury reported.

Manufacturer Narrative

The hospital's biomed was seeking dräger's assistance and provided certain error codes for diagnosis which he found in the log file.Based upon these error codes it was recommended to the biomed to replace the ventilator motor.This has corrected the problem; the device is back in use.The old motor was not returned for dräger for evaluation.In reflection of the device age, 19 years, it can be assumed that the shut-down of automatic ventilation was triggered upon speed fluctuations caused by abrasion of the collector disc.It is known from other complaints that an intermittent contact between the carbon brushes and the collector disc may cause such speed fluctuations of the motor which results in a deviation between calculated an measured piston position.This may have the consequence of potentially hazardous ventilator output or damages to the ventilator unit.Thus, the system is designed to shut down automatic ventilation and to post a corresponding alarm.The intention is that patient support can be done in manual ventilation which is confirmed to have worked for the particular surgical procedure.The number of similar cases is within the foreseen range of the risk management and thus accepted.The particular motor has lasted much longer than the average expected lifetime.

Event Description

It was reported during use that the unit displayed vent failure.The patient was bagged until the end of the case and there was no patient injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 11736370
• MDR Text Key: 250866117
• Report Number: 9611500-2021-00181
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2021
• 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
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1