MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA ATLAN A350; ANESTHESIA UNITS

Catalog Number 8621500

Device Problems Incorrect Interpretation of Signal (1543); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2022

Event Type  malfunction  

Event Description

During internal review, it was detected that the event was reportable due to the occurred vent fail during use.There was no patient injury reported.

Manufacturer Narrative

Based on the logfile analysis, the case in question could be reconstructed and could be traced back to condensed water inside the pneumatic path affecting the airway pressure monitoring and leading in the following to the ventilator-shutdown.The occurrence of condensation in the pneumatic circuit is a procedural problem, not related to the workstation itself; it occurs mostly during minimal and low flow anaesthesia procedures and/or surgeries that are extended to several hours.The workstation is able to detect the presence of condensed water inside the pneumatic path - either during system test or during use.If the error condition is being detected during the system test, the device indicates this with information displayed in the test result overview.If occurring during use, the issue will trigger a corresponding alarm.A ventilator shutdown will only be forced if a second error condition is present in parallel.If, for example the condensation affects the airway pressure monitoring, as it was confirmed in this specific case, the protection against potentially hazardous output is compromised - an overpressure inside the pneumatic system cannot be detected then.Per safety concept the device is designed to shut down automatic ventilation.Since it is possible that water is in the system but is still below the limit to be detected by the device, the ifu contains a warning that the device needs to be checked for condensed water in the hoses and to remove the water if necessary.When performing the system test, as also described in the ifu, manual actions that need to be performed and acknowledged by the user are needed prior to the automatic part of the test.As part of the ¿manual tests¿ of the system test, the user is informed about the potential presence of condensation inside the pneumatic system as a remain of the previous procedure and the user is instructed to remove the water from the hoses.The manual tests take approximately 2 minutes to complete.The log analysis however shows that the user confirmed the manual tests within a few seconds; the logged test time was not nearly long enough to actually perform the tests.Thus, it can be concluded that the increasing water accumulation on the days was leading up to the reported event, that eventually led to the ventilator failure.Dräger finally concludes that there is no issue with the device which would require repair or correction.Appropriate risk mitigation measures are in place; some of them are under responsibility and control of the user.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: ATLAN A350
• 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: 17949101
• MDR Text Key: 325833680
• Report Number: 9611500-2023-00366
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2023

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 Catalogue Number: 8621500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NA.