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

Catalog Number 8606000

Device Problems Leak/Splash (1354); Sticking (1597); Device Stops Intermittently (1599); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

For analysis at manufacturer site no log file was provided but it was stated by the biomed looking at the logs that no error entry was found.This fits to the statement of the customer that the device did not alarm or go into vent fail during the event.The cosy was inspected by the biomed finding debris within the apl bypass valve causing it to stick open intermittently.As the apl bypass valve is open during automatic ventilation this could not be root cause of the reported problem.Based on the available information also a leak at the peep/pmax valve can be excluded as no corresponding error entry was found in the logs.Therefore the most likely root cause for the reported leakage is a fresh gas decoupling valve that temporary remained open maybe also caused by the debris which was found in the cosy.Following the recommendations of the ifu the cosy should be reprocessed on a regular base so that the presence of debris can be avoided.In case of a open fresh gas decoupling valve the fresh gas would flow backwards through the absorber to the ags resulting in a huge leak as reported.Due to the fact that the patient gas/ agent is permanently monitored a corresponding alarm e.G.Low tidal volume and low airway pressure would be issued by the device.That in this case the device did not alarm is only possible if the alarm limits for volume and pressure were not set or if the problem vanished before the fabius alarmed.The device was tested after the case and was returned to use.

Event Description

It was reported during a case that a patient could not be ventilated 2 times.The user reported there was a huge leak.It was determined upon examination of the machine that there was debris found in the cosy causing the valve to stick open intermittently.The machine was tested and returned for clinical use.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: 7117538
• MDR Text Key: 95196143
• Report Number: 9611500-2017-00388
• Device Sequence Number: 1
• Product Code: CBK
• 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: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2008
• 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