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

Catalog Number 8606000

Device Problems Tidal Volume Fluctuations (1634); Gas/Air Leak (2946); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/24/2019

Event Type  malfunction  

Manufacturer Narrative

The reported ventilator failure and further issues about leakages and volume not reached could be comprehended by means of the log file analysis.The log file shows one entry that is logged when the airway pressure (paw) has gone very negative (less than -10mbar) during a ventilator operating mode.The device alarms for "pressure negative" if the measured paw is < ¿6.5 mbar.As a precaution, the piston pressure controller stops the ventilator temporarily and the device alarms accordingly with ¿ventilator fail¿.Monitoring and manual ventilation remains functional.Since no further entries were found in the log file, it can be assumed that the negative paw was most likely related to the surgical case, e.G.To the use of an external bronchial suction system.The investigation revealed as well that the device had a leakage during use.The fabius is equipped with integrated volume monitoring.If the delivered minute volume is less then set/expected, a visible and audible alarm will be generated depending on the alarm limits adjusted by the user (for example ¿minute volume low").By analyzing the log file it was found that the device did not pass the leak test that was performed prior to the case in question.The instructions for use of the device describes that the leakage test should be performed and all detected leakages should be remedied before using the device.A dräger service technician was dispatched to service the machine and no indications for a device malfunction were found; the device passed testing and was returned to use with no further problems reported.Dräger finally concludes, that the device responded as specified upon the symptom; no patient consequences have been reported.

Event Description

It was reported that the fabius would not ventilate at the beginning of the case.Additionally, also a problem with leaks and tidal volume were reported.There was no patient injury reported.

• Brand Name: FABIUS TIRO
• 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: 8690147
• MDR Text Key: 148289998
• Report Number: 9611500-2019-00170
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042419
• 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: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• 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: 8606000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2009
• 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