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

Catalog Number	8621600
Medical Device Problem Codes	Failure to Deliver (2338); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still on-going.The results will be provided with a follow-up report.H3 other text : on-going.
Event or Problem Description
It was reported that the machine failed in the middle of a case with a "ventilator failure" message.The procedure was finished with the patient breathing spontaneously.No injury reported.
Additional Manufacturer Narrative
The device log file was analyzed for the reported date and time of event.A too high difference between the inspiratory and expiratory pressure values during inspiration were identified.During the inspiration phase the pressure in the ventilator, the inspiratory branch and the expiratory branch up to the closed peep/pmax valve should be nearly identical.In case of a significant deviation of these values the atlan issues a "ventilator failure" alarm and stops automatic ventilation as a safety precaution to prevent from wrong airway pressure and switches to man/spont ventilation.Further information from the customer was received that a kink in the tubing was present during the case in question.Such a kinked patient hose can result in a higher inspiratory than expiratory pressure during inspiration.As all other inspiratory and expiratory pressure values in the log file were found to be in the expected range and did not indicate a hardware problem with the sensors it can be concluded that the reported ventilator failure was caused by a kinked patient circuit (user error) and not by a technical device malfunction.The atlan has responded to the detected situation as specified and has posted the corresponding "vent fail" alarm" and has stopped the automatic ventilation.Based on the investigation results, the case must be reassessed and is categorised now as non-reportable.
Event or Problem Description
It was reported that the machine failed in the middle of a case with a "ventilator failure" message.The procedure was finished with the patient breathing spontaneously.No injury 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: 17779817
• Report Number: 9611500-2023-00323
• Device Sequence Number: 12481796
• Product Code: BSZ
• UDI-Device Identifier: 04048675556183
• UDI-Public: (01)04048675556183(11)220228(93)8621600-13
• Combination Product (Y/N): N
• 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): 11/22/2023

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 Catalogue 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: 08/22/2023
• Supplement Date Received by Manufacturer: 11/10/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 11/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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