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

Catalog Number 8604700

Device Problem Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still ongoing.The results will be provided within a follow-up report.

Event Description

It was reported that at the beginning of a case the device displayed vent failure and check apl valve.There was no patient injury reported.The device was switched and the case continued.

Manufacturer Narrative

According to the initial report a "check apl valve" alarm was posted by the device indicating a problem of the apl bypass valve.Analysis on-site by a service technician revealed that a pinched vacuum hose to the apl bypass valve has caused the reported ¿check apl valve¿ alarm.During automatic ventilation the apl bypass valve is opened to bypass the apl valve.In manual mode the apl bypass valve is closed so that the maximum airway pressure can be set at the apl valve.If the vacuum hose to the apl bypass valve is pinched the apl bypass valve remains closed during automatic ventilation so that the breathing gas cannot leave the system as long as the pressure is below the value set at the apl valve.With a pinched hose to the apl bypass valve the leak and compliance test as part of the mandatory pre-use check is not passed.The device log file was analyzed for the reported date of event.No ¿ventilator failure¿ entry was found; but the entry ¿vent restart¿ was logged.This occurs if the device detects an airway pressure of more than 10mbar above the pmax limit set by the user.This is a protective function to prevent an overpressure condition for the patient.If the triggering condition disappears within 400ms the device will just perform a position zeroing manoeuver and the interrupt in ventilation will probably not even be noticed by the user.Since the vent restart was triggered by a pressure peak and may have only affected one single ventilator hub at the utmost, it is being concluded by the manufacturer that there is no issue with the device requiring repair or correction regarding the ¿vent restart¿ log entry.The pinched hose was repaired by rerouting of the hoses.The device was successfully tested afterwards and was returned to use.The number of similar cases related to the same root cause (pinched hose of apl bypass valve), is within the expected range of the respective risk assessment and thus accepted.

Event Description

Please refer to the initial-report.

• Brand Name: FABIUS GS
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 8563924
• MDR Text Key: 143706095
• Report Number: 9611500-2019-00134
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 8604700
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1