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

Catalog Number 8621500

Device Problems Complete Blockage (1094); Gas Output Problem (1266); Incorrect Interpretation of Signal (1543); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that the device failed during use.The problem occurred several times in a row.Ventilation stopped and manual ventilation was required.The automatic ventilation was restarted and ventilation stopped again after a few seconds.No injury was reported.

Manufacturer Narrative

The investigation was just started.The result will be forwarded in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the device failed during use.The problem occurred several times in a row.Ventilation stopped and manual ventilation was required.The automatic ventilation was restarted and ventilation stopped again after a few seconds.No injury was reported.

Manufacturer Narrative

For the investigation the provided log file was analyzed.No technical failure was found.The described ventilator failure could be reconstructed.The root cause was a pressure difference between the inspiratory and expiratory pressure values during inspiration.The atlan reacted as specified and switched to man/spont configuration in accordance with its safety concept and indicated this to the user.The reason for this may be an excessive breathing tube resistance, for example due to soaked filters or kinked tubes.The occurrence of condensation in the pneumatic circuit is a procedural problem, not related to the workstation itself.A hardware error is unlikely as the pressure sensors are checked regularly during the system test and during operation.The provided pba connectorboard was analysed.No deviations from specification were found.Dräger finally conclude that the measured pressure difference was a temporary problem.Appropriate risk mitigation measures are in place; some of them are under responsibility and control of the user.Based on the investigation results, the case was re-assessed as non-reportable.

• 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: 18776008
• MDR Text Key: 336184137
• Report Number: 9611500-2024-00078
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K230931
• 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: 05/16/2024

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/12/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2023
• 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
• Treatment: NA.; NA.