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

Catalog Number 8607000

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation was performed based on the provided complaint and service information.We were informed that after replacement of the bacteria filter the reported problem was resolved.Although the fabius is equipped with two bacteria filters on different positions only the one installed in the vacuum line (inside the fabius control box) can cause, if blocked, a ventilator failure as reported.A blockage of this specific bacteria filter will lead to a high membrane vacuum finally exceeding the maximum value for automatic ventilation (approx.-250mbar).The vacuum pressure is necessary to maintain proper function of the ventilator piston diaphragm.As a precaution in such case the ventilator is stopped and a corresponding "ventilator fail" alarm is posted.As automatic ventilation is not possible anymore the user can switch to manual ventilation as described in the instructions for use.Monitoring is still functional.The affected filter is part of the yearly preventive maintenance.As the 4 years old fabius is not under draeger service contract and as no information was provided when the last maintenance was performed it is unknown when the bacteria filter was replaced the last time before the reported event took place.The fabius has reacted as specified for the detected situation and has posted appropriate alarms to inform the user.

Event Description

It was reported there was a vent fail message posted during a case.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 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; lübeck 23542 ; GM 23542 ; 4518822868
• MDR Report Key: 8979159
• MDR Text Key: 175032322
• Report Number: 9611500-2019-00269
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2000
• Device Catalogue Number: 8607000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2014
• 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