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

Model Number	8621500
Medical Device Problem Codes	Gas Output Problem (1266); Failure to Deliver (2338); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation was just started, the result will be forwarded in a follow up report.
Event or Problem Description
It was reported that at around 9.38 p.M., the anaesthesia machine failed during an emergency procedure with heart lung machine involvement in hch operating room 2."ventilator failure".Changeover of the anesthesia machine to manuel mode without problems and subsequent start-up of another ventilator in order to continue mechanical ventilation.No injury reported.
Additional Manufacturer Narrative
For the investigation the logfile was analysed.It was found that the system test was completed successfully before and after the event.The device detected during operation implausible values when comparing the signals for inspiratory and expiratory pressure, while it can be excluded that this was due to defective sensors.The difference between the inspiration pressure is more than three times as large as the pressure in the expiration.The device posted the corresponding "airway pressure high" alarms.In the consequence the device switched off the automatic ventilator for safety measures which was accompanied by the corresponding ¿ventilator failure¿ alarm.Manual ventilation remained possible.Possible reason for such an implausible pressure is a sporadic high resistance in the hose system due to sqeezed hoses, patient activity or respositioning the patient.However it was not possible to determine the root cause more precisely.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.
Event or Problem Description
It was reported that at around 9.38 p.M., the anaesthesia machine failed during an emergency procedure with heart lung machine involvement in hch operating room 2."ventilator failure".Changeover of the anesthesia machine to manuel mode without problems and subsequent start-up of another ventilator in order to continue mechanical ventilation.No injury reported.

• Brand Name: ATLAN A350
• Common Device Name: 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: 22140794
• Report Number: 9611500-2025-00286
• Device Sequence Number: 12518347
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)240411(93)8621500-17
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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
• Operator of Device: Health Professional
• Device Model Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown