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 09/12/2023

Event Type  malfunction  

Event Description

It was originally conveyed the device would not turn on after the patient was connected to the device, but once the draeger fse was on site it was conveyed there was a vent fail in the middle of the case.There was no injury reported.

Manufacturer Narrative

The presence of a ventilator failure was confirmed during on-site check and traced back to the ventilator motor which was worn after almost 11 years of use.In fact, the log file of the device indicates that it has never been switched off after putting it into use for the first time.By doing so, there is a permanent flow of electrical current through the motor; the device adapts the piston position to each change of atmospheric pressure during standby.The motor is designed to last for a minimum of 10 years at standard operation conditions and, post market surveillance data confirms that this is fulfilled in general.It is however not known which long-term effects result from the permanent exposition to current flow.The case is considered a single event.The typical wear effect is that the collector disc becomes worn which leads to positions at the circumference where the electrical contact to the carbon brushes is interrupted and no mechanical power will be provided to the rotor.This leads to speed fluctations and can cause a divergence between the expected piston position and the measured one.To protect the patient from potentially hazardous output the device is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.Manual ventilation via the built-in breathing bag remains possible including gas dosage.

• 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17948900
• MDR Text Key: 325827483
• Report Number: 9611500-2023-00365
• 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: 10/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• 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: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2012
• 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