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

Catalog Number 8608555

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Gas/Air Leak (2946); Misassembly by Users (3133); Physical Resistance/Sticking (4012)

Patient Problems Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2023

Event Type  Injury  

Manufacturer Narrative

The investigation was just started, the results will be forwarded in a final report.H3 other text : on-going.

Event Description

It was reported that the fabius plus xl alarmed a ventilator failure, an ags valve failure and an expiratory branch failure.It was reported that the patient had to be reanimated and is now in stable conditions.

Manufacturer Narrative

The log file was available for investigation.It was reported the device alarmed for "ventilator lock" and "ags valve failure".It is assumed that the alarms ventilator fail !!! and check apl valve !!! are meant (ags valve failure alarm do not exist).In the beginning the device detected a motor overcurrent.Automatic ventilation was shut down and corresponding alarms issued.The technician found a wrinkeled inner diaphragm of the motor.Potentially, an incorrect assembly of the inner diaphragm during service a few weeks before the reported date of event caused the wrinkled diaphragm resulting in a blockade of the ventilator.Further, an expiratory flow of more than 15ml was measured and alarmed with ex port leakage.This alarm do only occur in automatic ventilation.As the device shut down automatic ventilation it is unknown and not reproducible, that this alarm/log entry was registered after the ventilator shutdown.However, according to the log entries no hint for a trigger of a barotrauma was found.The device generates the alarm airway pressure high depending on the set upper peak alarm limit, if the inspiratory pressure increases.In this case the device limits the ventilation pressure and alarms pressure limiting.During manual ventilation the pressure is limited by the apl valve.Additionally, a high pressure safety relief valve ensures patient protection against high ventilation pressure.It can be concluded that the device reacted as specified.The root cause is unknown.

Event Description

It was reported that the fabius plus xl alarmed a ventilator failure, an ags valve failure and an expiratory branch failure.It was reported that the patient had to be reanimated and is now in stable conditions.He suffered a barotrauma.

• Brand Name: FABIUS PLUS XL
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• Manufacturer Contact: moislinger allee 53-55; lübeck 23542 ; 4518822868
• MDR Report Key: 17222883
• MDR Text Key: 318073256
• Report Number: 9611500-2023-00242
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675377610
• UDI-Public: (01)04048675377610(11)190910(17)200205(93)8608555-28
• Combination Product (y/n): N
• PMA/PMN Number: K011404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8608555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• 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
• Patient Outcome(s): Life Threatening; Required Intervention