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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Electrical Overstress (2924)

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

Event Date 10/12/2022

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 towards the end of a case the device displayed a vent fail message/alarm.No patient injury reported.

Event Description

It was reported that towards the end of a case the device displayed a vent fail message/alarm.No patient injury reported.

Manufacturer Narrative

Initially two events of ventilator failure were reported.The investigations were performed separately in two pr cases.(b)(4) the provided log file showed for the date of the second ventilator failure entries for persistent excessive piston motor current.The replaced ventilator motor was returned to the manufacturer site in lübeck and was tested.It passed the endurance test and the motor showed no suspicious behavior.The parts which were replaced in consequence of the first occurrence were not available for investigation and the provided log file did not show the entire day on which the first occurrence was reported.Therefore an expedient log file analysis was not possible.As the failure could not be reproduced and additional information/parts are missing no detailed root cause for the reported event could be determined.In the case automatic ventilation shuts down the alarm ventilator fail will be given.The user can switch to manual ventilation as described in the instructions for use.

• 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
• MDR Report Key: 15787223
• MDR Text Key: 307894122
• Report Number: 9611500-2022-00307
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675041467
• UDI-Public: (01)04048675041467(11)141210(93)8607000-60
• 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: 03/21/2023

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: 8607000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2022
• Initial Date FDA Received: 11/14/2022
• Supplement Dates Manufacturer Received: 03/17/2023
• Supplement Dates FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• 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