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); Pressure Problem (3012)

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

Event Date 05/14/2022

Event Type  malfunction  

Event Description

It was reported during a case the unit displayed a ventilator failure message.There was no patient injury reported.Remark: it was determined during a review of records that the decision to report this case was filed within the applicable time frame but due to internal miscommunication / human error the report was not submitted.

Manufacturer Narrative

The device was inspected by an engineer of the dräger field service.The reported ventilator failure could be confirmed and traced back to a loss of the auxiliary vacuum pressure inside the ventilator unit.It could be traced back to a worn lower piston diaphragm.The piston diaphragm has been replaced; the device passed all consecutive tests and was returned to use.The auxiliary vacuum pressure is required to keep the ventilator diaphragm in place during piston movement and to actuate the valves which control the ventilation cycles.If the vacuum pump cannot build-up the necessary pressure level due to e.G.A leakage in the pneumatic circuit; automatic ventilation is not possible.If this condition is present already during pre-use check the device will respond with a failed self-test result.In case of occurrence during use the device will force a shut-down of automatic ventilation and post a corresponding alarm.The fabius gs premium workstation is subject to routine preventive maintenance in regular intervals; checking the piston diaphragms every two years is part of the standard procedure.Post market surveillance data confirms that this interval is in general appropriate.The particular device was in operation for almost 12 years now.Dräger has no records if the diaphragm has even been replaced since then because the device is not under a service contract.Dräger finally concludes that the device responded as designed upon an error condition that was most likely related to lack of preventive maintenance.

• 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: 15500469
• MDR Text Key: 306291943
• Report Number: 9611500-2022-00254
• 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
• Report Date: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• 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: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2010
• 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