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

Catalog Number 8607000

Device Problems Intermittent Continuity (1121); Gas Output Problem (1266); Failure to Deliver (2338)

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

Event Date 09/28/2021

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 there was a ventilator failure.No injury reported.

Event Description

It was reported there was a ventilator failure.No injury reported.

Manufacturer Narrative

The investigation results regarding the complaints (b)(4) (mdr report no.9611500-2021-00427) and (b)(4) (mdr report no.9611500-2021-00440) are summarized in this letter as the same event has occurred twice in succession on the same device.After the first occurrence of the failure the real cause was not determined during investigation within (b)(4) so that the failure arose again.Therefore, a second complaint (b)(4) was opened.During on-site service after occurrence of the first event the lower diaphragm of the ventilator was found to be installed inside out and was assessed as likely root cause for the reported event.Therefore, the unit was returned to clinical use after repair.Log analysis at manufacturing site confirmed an issue with the ventilator on the date of event, (b)(6) 2021.It could be comprehended that the supervisor function of the software forced a shutdown of automatic ventilation after detecting a stalled motor.This is a safety measure to prevent from mechanical damages to the ventilator unit.The user is alerted to the shutdown of automatic ventilation by a corresponding alarm; manual ventilation remains possible and, the other device functions like gas dosage and monitoring remain unaffected.On (b)(6) 2021, again a ventilator failure has occurred so that a second complaint (b)(4) was opened.The unit was serviced by a draeger technician and the same log entries were found as for the first event- automatic ventilation was stopped due to a stalled motor.Although the issue could not be duplicated on site the ventilator motor, the incremental encoder cable, the light barrier cable, and the membranes in the ventilator were replaced as a precautionary measure.Furthermore, the technician detected that upon disassembly of the components the motor cable connection to the cpu board was found to be not seated firmly.The replaced parts were available for investigation and were assembled in a test unit without showing the reported failure.Finally, the reported issue could be reproduced by detaching the ventilator motor cable during an active ventilation.But it was not possible to determine what caused the detachment of the cable during the case in question.As no further similar cases are known the case was assessed as a single event.The unit was successfully tested on site and is ready for clinical 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: 12665274
• MDR Text Key: 279831758
• Report Number: 9611500-2021-00427
• 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: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• 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: 12/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2011
• 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