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

Catalog Number 8607000

Device Problem No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation was carried out based on the logfile of the reported date of event.It was found that only 3 events have been logged on the reported date of event: two entries have been logged when the device was switched on, at 07:16 am and at 02:16pm.The third entry is that a "m006 paw very neg" entry has been logged at 01:37pm.A "m006 paw very neg" is logged when the airway pressure (paw) has gone very negative (less than -10mbar) during a ventilator operating mode.The entry correlates with the reported time of event at 02:00 pm and is most likely related to the reported loss of pressure.A high priority "pressure negative" alarm is issued even before when the airway pressure (paw) drops below only -5 mbar.Therefore, the fabius in question must have issued at least one high priority "pressure negative" alarm.As reported in this specific case, the device generated according alarms.If the system has been losing pressure, the root cause is most likely a leakage in the system.On-site, the device passed all the test during inspection by the dräger service technician and no malfunction could be found.Therefore, the leak has most likely been at the breathing circuit that has been disposed after the case.Any leak above 250 ml/min within the breathing system will be identified and alarmed during the leak and compliance test of the pre use check.The device was returned to use after the testing with no further problems reported since then.

Event Description

It was reported the fabius was loosing pressure during pressure support mode.There was no injury to the patient.

• Brand Name: FABIUS GS PREMIUM
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer (Section G): DRAEGERWERK AG & CO. KGAA; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• Manufacturer Contact: sonja hillmer ; moislinger allee 53-55; luebeck, 23542 ; GM 23542
• MDR Report Key: 7713455
• MDR Text Key: 114809349
• Report Number: 9611500-2018-00241
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• 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: 06/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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