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

Catalog Number 8604700

Device Problems Device Reprocessing Problem (1091); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Event Description

It was reported that the device will not ventilate.No patient injury was reported.

Manufacturer Narrative

The provided log file showed an entry for vent pressure very negative.This event is logged when negative pressure is measured inside the ventilator cylinder when the piston moves down.The piston pressure controller stops the ventilator temporarily as a precaution and the device alarms for ventilator fail.This indicates an issue with the -8mbar valve on the top of the ventilator cover.It can dose ambient air into the cylinder in case of insufficient fresh gas flow.As the ventilator lid was replaced, it can be assumed that this resolved the issue.The device was fully functional afterwards.It is known that the -8mbar valve on the top of the ventilator cover tends to stick if the cleaning recommendations of the instructions for use are not followed.In this case ventilation resumes if the diaphragm detaches from the crater and pressure increases above ¿ 5mbar.

Event Description

It was reported that the device will not ventilate in pressure support and pressure control.A fresh gas low alarm was given.No patient injury was reported.

• Brand Name: FABIUS GS
• 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: 16231656
• MDR Text Key: 308956014
• Report Number: 9611500-2023-00024
• 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,Followup
• Report Date: 10/23/2023

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: 8604700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2004
• 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
• Treatment: NA.; NA.