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	06/10/2025
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 the atlan therapy wasn't improving the patients condition so there are possibly 2x disconnects from the atlan to hamilton -t1 ventilators, then a reconnection to the atlan.There were a number of alarms which would be associated with no manspont flow.There was also a ventilator fail alarm.No injury was reported.
Additional Manufacturer Narrative
Based on the logfile analysis, the case in question could be reconstructed and no indications for a device malfunction were found.During the initial phase of the therapy (07:02am to 07:22am), apnea alarms were given several times indicating a large external leakage (e.G.In the tube or mask).After switching into vc-af (volume-controlled ventilation with auto-flow), i.E.Automatic ventilation mode, o2 and co2 values were constant and inconspicuous and also, no leakage was visible and the set peep of 3mbar was maintained.A vt of 65ml was set and a pmax of 25mbar.The maximum measured pressure was at the upper end of the set range at around 25mbar.The tidal volume was around 50ml.When the pmax was changed from 25mbar to 30mbar at 07:52am, the maximum measured pressure levelled up to around 30mbar and the tidal volume increased as well to then constantly 65ml.This behaviour is typical for the used ventilation mode.In this mode, ventilation is volume-controlled, but with the attempt to work as gently as possible on the lungs meaning that the measured pressure has an influence on the applied tidal volume.In case of high pressure, less volume within a certain range is applied in order to ventilate in a protective manner.However, it could also be identified that a high resistance was present in the entire system during the particular case ¿ values for the patient resistance of consistently around 100mbar (instead of normally expected 50 to 70mbar) were measured.At 08:43am, a ¿ventilator failure¿ was alarmed due to implausible values being measured for the inspiratory and expiratory pressure sensor.Due to the implausible pressure values, the ventilator was switched off for safety reasons.Ventilation can be continued in man/spont, which was also done in the particular case.Dräger finally concludes that the large external leakage at the beginning of the therapy was causing the reported difficulties to ventilate the patient.From the time of switching to the automatic ventilation, a very high patient resistance was detected which could have been caused by e.G.Clogged filters, kinked tubes or large accumulations of water in the tubes.There were no indications for a device malfunction found.The device finally behaved as specified upon the detected implausible pressure values by initiating an emergency shutdown of automatic ventilation which was accompanied by the corresponding alarm to alert the user.The device is equipped with an integrated pressure-, flow- and patient gas monitoring ensuring that deviations from set/expected parameters are obvious for the user and that alarms are given according to the alarm limits adjusted by 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.
Event or Problem Description
It was reported that the atlan therapy wasn't improving the patients condition so there are possibly 2x disconnects from the atlan to hamilton -t1 ventilators, then a reconnection to the atlan.There were a number of alarms which would be associated with no manspont flow.There was also a ventilator fail alarm.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: 22402918
• Report Number: 9611500-2025-00352
• Device Sequence Number: 8353613
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)220120(93)8621500-13
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 08/25/2025

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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 07/04/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.; NA.
• Patient Sex: Unknown