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

Catalog Number 8607000

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that during use a "ventilator fail" alarm was posted.No injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

The log file evaluation revealed that the device forced a shut-down of automatic ventilation during the procedure in question after having detected a deviation of the ventilator motor's rotation speed.To protect the patient from potentially hazardous output, motor position, rotation speed and acceleration must be monitored continuously.If the measured values have a significant deviation from the ones calculated by the software, the system is designed to shut-down automatic ventilation for safety reasons.The user will be alerted by means of a corresponding alarm; manual ventilation including monitoring remain available.Based on the entries found the cause can be traced back to the ventilator motor or the position detection system.Nevertheless, during on-site evaluation a faulty vacuum pump was determined as root cause.After replacement of the pump the problem was initially solved until it occurred again in the repair workshop two months later.The motor, pneumatic assembly and main board were then replaced.All replaced components were requested and sent, but only the motor was received for investigation.The motor was subject to an in-depth evaluation in the manufacturer's lab but the reported ventilator failure could not be reproduced.Therefore, the exact root cause could not be determined.Finally, it can be concluded that the device has reacted to the situation as specified.

Event Description

It was reported that during use a "ventilator fail" alarm was posted.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: 15416764
• MDR Text Key: 299847095
• Report Number: 9611500-2022-00235
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)200225(17)200811(93)8607000-75
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• 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: 03/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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