MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA FABIUS GS; ANESHESIA 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 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the ventilator stopped cycling during a case and started working again after a short period of time.No injury reported.

Event Description

It was reported that the ventilator stopped cycling during a case and started working again after a short period of time.No injury reported.

Manufacturer Narrative

The dispatched dräger fse tested the device and did not determine any persisting ventilator failure with the device.Based on log file analysis the case could be reconstructed as follows: during downward movement of the piston the device detected that a negative pressure has been built-up to a certain level which is an indication for a fresh gas deficit.In such situation the device is designed to open an auxiliary air intake valve on top of the ventilator to compensate the fresh gas deficit by taking-in ambient air.This did not work or the air intake was not proceeded fast enough, resulting in a further increase of the negative pressure.The device will then stop piston movement temporarily and post a vent fail alarm.If the negative pressure goes back below the threshold ventilation will resume automatically.As a preventive measure, the fse has replaced the ventilator lid where the auxiliary air intake valve is integrated; the workstation passed all consecutive tests and was returned to use.The auxiliary air intake valve was tested in the lab but did not exhibit any error conditions.It is seen likely that humidity has led to sticking or delayed opening of the valve.Based on experience this is caused by insufficient reprocessing.Traces are hardly to determine afterwards as the humidity will likely evaporate during the return shipment before the part can be tested.The root cause for the fresh gas deficit which stands at the beginning of the chain of contributing factors cannot be determined by log file analysis.It cannot be excluded that the operator setting for the fresh gas flow was insufficient for the particular patient.

Manufacturer Narrative

Due to a technical issue with our internal emdr system we submitted for the form fda 3500a an incorrect value for the field h3.- not returned to manufacturer.

Event Description

It was reported that the ventilator stopped cycling during a case and started working again after a short period of time.No injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESHESIA 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: 12689340
• MDR Text Key: 280531980
• Report Number: 9611500-2021-00438
• 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,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2002
• 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