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

Catalog Number 8607000

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

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

Event Date 11/16/2021

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 during use a ventilator failure was posted.The case was cancelled and was rescheduled.No injury reported.

Manufacturer Narrative

The investigation was performed based on the error messages which reportedly were posted during the case in question as no error log was available.The reported error message "membrane pressure low" indicates that the device had shut down automatic ventilation during the course of event due to a problem with the auxiliary vacuum pressure.The device needs a vacuum pressure inside the piston to keep the piston diaphragm in place i.E.To avoid wrinkling of the diaphragm during piston movement.If this vacuum pressure drops below a certain threshold necessary for safe operation the device is designed to shut down automatic ventilation to prevent from serious damages to the ventilator unit.The shut-down is accompanied by a corresponding alarm; patient support can be continued in manual ventilation with the built-in breathing bag.The root cause of the low vacuum pressure could not be determined during on-site examination.The motor was replaced as a precautionary measure but is not in context with the reported symptom.Calibrations were performed and a self test was passed successfully.The device was tested and confirmed to be operating per manufacturer¿s specification being ready for clinical use.Dräger finally concludes that the workstation responded as designed upon a sporadic deviation; automatic ventilation was shut down to avoid severe damages and the user was alerted to the shut-down by means of a dedicated alarm.

Event Description

It was reported that during use a ventilator failure was posted.The case was cancelled and was rescheduled.No injury reported.

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.Device not returned to manufacturer.

Event Description

It was reported that during use a ventilator failure was posted.The case was cancelled and was rescheduled.No injury reported.

• Brand Name: FABIUS GSP
• 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: 13025381
• MDR Text Key: 284303944
• Report Number: 9611500-2021-00507
• 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: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8607000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2008
• 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
• Patient Outcome(s): Other