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

Model Number	8621600
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Deliver (2338); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on going.The results will be provided with a follow-up report.
Event or Problem Description
It was reported that the device had discrepancies on o2 readings.Log analysis revealed that also a ventilator failure occurred on the reported date/time of event.No injury reported.
Additional Manufacturer Narrative
The device log was analyzed for the reported date of event.It was found that the o2 and co2 sensors did not detect any metabolism.The inspiratory and expiratory values remained the same.It can be assumed that probably another device was used for o2 and co2 monitoring.Questions were asked for clarification, but unfortunately were not answered.In addition, the o2 concentration sometimes dropped from the set ~100% to ~21% within 15 seconds, which indicates that ambient air was being drawn in via the sample line.Questions were also asked about this, but also remained unanswered.The integrated patient gas monitoring ensures that deviations from set/expected gas concentrations are obvious and alarmed depending on the limits adjusted by the user.Neither ventilation nor gas delivery will be affected, as gas readings are not used for control purpose.The in-depth log analysis has revealed that during the initial log evaluation the entry ¿no movement from pisten¿ was incorrectly interpreted as a vent fail.For the current case the ventilator was temporarily stopped due to a negative airway pressure but did not result in a peep drop to ambient air.Corresponding alarms were posted to inform the user about the situation.No hints for a device malfunction found.We have been informed that the device is back in operation and that no further problems have occurred since then.Finally, based on the available investigation results, the case is retrospectively assessed as not reportable.Note: in the first follow-up report for this case the coding was incomplete.This was now added.
Event or Problem Description
It was reported that the device had discrepancies on o2 readings.Log analysis revealed that also a ventilator failure occurred on the reported date/time of event.No injury reported.
Additional Manufacturer Narrative
The device log was analyzed for the reported date of event.It was found that the o2 and co2 sensors did not detect any metabolism.The inspiratory and expiratory values remained the same.It can be assumed that probably another device was used for o2 and co2 monitoring.Questions were asked for clarification, but unfortunately were not answered.In addition, the o2 concentration sometimes dropped from the set ~100% to ~21% within 15 seconds, which indicates that ambient air was being drawn in via the sample line.Questions were also asked about this, but also remained unanswered.The integrated patient gas monitoring ensures that deviations from set/expected gas concentrations are obvious and alarmed depending on the limits adjusted by the user.Neither ventilation nor gas delivery will be affected, as gas readings are not used for control purpose.The in-depth log analysis has revealed that during the initial log evaluation the entry ¿no movement from (b)(4)¿ was incorrectly interpreted as a vent fail.For the current case the ventilator was temporarily stopped due to a negative airway pressure but did not result in a peep drop to ambient air.Corresponding alarms were posted to inform the user about the situation.No hints for a device malfunction found.We have been informed that the device is back in operation and that no further problems have occurred since then.Finally, based on the available investigation results, the case is retrospectively assessed as not reportable.
Event or Problem Description
It was reported that the device had discrepancies on o2 readings.Log analysis revealed that also a ventilator failure occurred on the reported date/time of event.No injury reported.

• Brand Name: ATLAN A350 XL
• 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 23558 ; GM 23558
• Manufacturer Contact: moislinger allee 53-55; lübeck 23558 ; 4518822868
• MDR Report Key: 22673712
• Report Number: 9611500-2025-00427
• Device Sequence Number: 15325117
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)220404(93)8621600-13
• 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,Followup
• Report Date (Section B): 11/06/2025

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: 8621600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 11/04/2025; 11/04/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 11/06/2025; 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2022
• 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
• Patient Sex: Unknown