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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Decreased Pump Speed (1500); Failure to Deliver (2338)

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

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

The device was subject to an on-site evaluation by a dräger service engineer.The reported issue of a ventilation shut down during use could be confirmed by log file analysis: the records stored therein indicate that the supervisor software detected a deviation between calculated and measured piston position.The piston hub defines the applied tidal volume and thus, to prevent from potentially hazardous output and/or from damages to the ventilator unit, the system is designed to shut down automatic ventilation and to alert the user to this condition by means of a corresponding alarm.The issue may be a "real one" related to wear and tear of the motor itself or a "virtual one" caused by issues with the piston position detection system - both conditions will result in the same log file entry.A differentiation is not possible without inspection of the hardware for which the entire device has to be disassembled.The customer has not responded so far upon the repair quotation and thus, neither was an in-depth investigation performed nor is a reliable conclusion in regard to the exact root cause possible.It can only be concluded that the device responded as designed upon the measured piston position divergence and has shut down automatic ventilation while posting a corresponding alarm.

Event Description

It was reported that the unit had a ventilator failure during a case.There was no 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
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 18967128
• MDR Text Key: 338616647
• Report Number: 9611500-2024-00127
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)210324(17)210809(93)8607000-76
• Combination Product (y/n): N
• PMA/PMN Number: K003068
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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