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

Model Number	8621500
Medical Device Problem Codes	Gas Output Problem (1266); Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was changed from man/spon mode to psv, which pop up with alarms, fresh gas low/leakage, air inlet activated alarm and no ventilation was happening.The anesthetic switch back to man/spon and then tried vc mode and the ventilator was not functional, and no piston movement was observed.This changing of modes tried few times, but the ventilator failed to respond without any alarm in vc mode.The case was completed with man/spon emergency ventilation.No injury was reported.
Additional Manufacturer Narrative
The investigation was just started, the report will be forwarded after the investigation was closed.
Additional Manufacturer Narrative
For the investigation the provided logfile was analysed.The described alarms could be retraced.The case in question was started in man/spont mode.Initially, no inspiratory or expiratory flow was measured but a negative airway pressure.This was detected and alarmed optically and acoustically with "airway pressure negative".It is likely that an external suction system was used as the device also detected and alarmed an external leakage.Further the device alarmed for a "breathing system failure".According to the logfile a pump pressure failure on the piston membrane was the root cause for this.It can be assumed that the measured negative pressure was the root cause for this, as it was not possible to maintain a stabile pressure at the membrane.The device was than switched into different automatic ventilation modes.The device again alarmed with "fresh gas low or leakage" and "ambient air inlet activated".Root cause for this was most likely a large external leakage.The logfile does not show a technical failure or a stop of ventilation.It can be seen in the logfile that the piston moves, also it can be seen that there is a o2-uptake from the patient in automatic ventilation mode.It is assumed that two conditions have come together in this case.Negative pressure was introduced into the system, probably by an external suction system.Further a large external leakage was present.The device recognized both the negative airway pressure and the leakage and triggered the adequate alarms accordingly.Based on the investigation results, the case was re-assessed as non-reportable.
Event or Problem Description
It was reported that the device was changed from man/spon mode to psv, which pop up with alarms, fresh gas low/leakage, air inlet activated alarm and no ventilation was happening.The anesthetic switch back to man/spon and then tried vc mode and the ventilator was not functional, and no piston movement was observed.This changing of modes tried few times, but the ventilator failed to respond without any alarm in vc mode.The case was completed with man/spon emergency ventilation.No injury was 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: 22438817
• Report Number: 9611500-2025-00363
• Device Sequence Number: 4593485
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)240527(93)8621500-17
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2025

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?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• 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