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

Model Number	8621500
Medical Device Problem Codes	Output Problem (3005); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation was just started.The result will be forwarded in a follow up report.
Event or Problem Description
It ws reported that there was an incident with patient injury during a treatment on (b)(6) 2024.According to initial information, the incident occurred during the induction of anesthesia.
Additional Manufacturer Narrative
For the investigation the provided logfile was analysed.It was found that during the initial self test the device detected and alarmed a leakage.According to the corresponding error code in the log file the leakage was located at the o2 sensor port or in the breathing system.As the self test was repeated after 15 min without a deviation, it seems plausible that the user was able to remove the leakage.During the following manual ventilation the device detected and alarmed for "apnoe (flow)".The device was switched over to automatic ventilation, however it was not possible to maintain sufficient ventilation.Only 35 ml were detected at the inspiratory flow sensor when vt was set to 500 ml.According to specification alarms were generated "tidal volume not achieved", "minute volume low" and "breathing system failure¿.Origin of this leakage was again at the o2 sensor port or in the breathing system.Short time after this the device detected and alarmed pressure peaks (ppeak at 41 mbar / pmax set = 30mbar).It is likely this was caused by external activities or patient activities, as the leakage was still present.It was concluded that the device detected a leakage and issued the adequate alarms.The issue occured on (b)(6) 2024, it was not possible to determine the exact root cause more precisely afterwards.
Event or Problem Description
It ws reported that there was an incident with patient injury during a treatment on (b)(6) 2024.According to initial information, the incident occurred during the induction of anesthesia.

• 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: 22094355
• Report Number: 9611500-2025-00280
• Device Sequence Number: 15468969
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)200330(93)8621500-08
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 07/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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): Initial
• Initial Date Received by Manufacturer: 05/23/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown