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

Catalog Number 8604700

Device Problems Gas Output Problem (1266); Tidal Volume Fluctuations (1634); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

As reported, neither logfiles nor further information were available - it was further reported that the device will remain out of use and be replaced with a new unit.Based on the available information, most likely an expiratory valve leakage led to the reported symptom.However, an expiratory valve leakage does not lead to a stop of ventilation.It was plausible that bigger leak flows caused deviations from desired tidal volume that were interpreted as stop of ventilation.In general, in case the device measures an expiratory flow of more than 15 ml during inspiration, an alarm message ¿ex port leakage¿ will be generated, as it was reported in the particular case.Automatic ventilation remains unaffected.The integrated pressure-, volume- and o2-monitoring of the fabius device ensures that visible and audible alarms will be generated if the delivered tidal volume is less then set/expected.Based on the experience from other cases, this symptom most likely is related to a leakage in the mechanical section of the peep valve inside the cosy.In the framework of continuous product improvement, a design change of the peep valve has already been started.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

Event Description

It was reported that the device got an "expiratory port leak" message and stopped ventilating during a case.The patient was bagged and the case was completed.There was no patient injury reported.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 9731332
• MDR Text Key: 186765792
• Report Number: 9611500-2020-00049
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8604700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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