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

Model Number	8621600
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	09/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the log file revealed that the supervisor function of the software forced a shut-down of automatic ventilation to protect the patient from potentially hazardous output.An implausible divergence between the readings for inspiratory and expiratory pressures was measured.The log contains no hint for the potential presence of a hardware failure; the data shows that the pressure sensors were producing correct readings and the aspect that the device stayed in use all the time after event without further observations and passed system tests inbetween without deviations confirms the validity of that statement.The exact root cause for the measured divergence cannot be derived from the logs; a plausible scenario would be a squeezing of the breathing tubes due to e.G.Patient repositioning.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
There was a vent fail during use reported; it was confirmed that the event did not lead to health consequences for the patient.

• Brand Name: ATLAN
• Common Device Name: ANESTHESIA UNIT
• 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: 23655512
• Report Number: 9611500-2025-00651
• Device Sequence Number: 10123484
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)250728(93)8621600-20
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 11/26/2025

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): Initial
• Initial Date Received by Manufacturer: 09/29/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2025
• 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