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

Catalog Number 8621500

Device Problems Gas Output Problem (1266); Failure to Deliver (2338); Pressure Problem (3012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be forwarded once the investigation is closed.H3 other text: on-going.

Event Description

It was reported that during anesthesia, only manual ventilation was possible and no other modes of ventilation were selectable.The buttons were without function.The surgery was completed with a different anesthesia machine.No injury was reported.

Event Description

It was reported that during anesthesia, only manual ventilation was possible and no other modes of ventilation were selectable.The buttons were without function.The surgery was completed with a different anesthesia machine.No injury was reported.

Manufacturer Narrative

The logbook provided was analyzed for the investigation.According to this, ventilation stopped on the day of the reported event.An internal leak in the breathing system was identified as the root cause and the vacuum pump was therefore unable to generate the required negative pressure.In accordance with the specification, the device alarmed with "error in the breathing system".In case the root cause cannot be eliminated by the user in this case, an emergency manual resuscitation bag must be used in accordance with the atlan instructions for use, as also described by the user.Technical problems with the vacuum pump, the pump control or leaks in the vacuum branch may be the cause of the fault.The vacuum pump was replaced and examined, but the pressure drop could not be reproduced and no technical fault could be detected.However, the device has been back in operation since november 21 without any further events as described.We therefore assume that the leakage was solved during the replacement of the vacuum pump.Furthermore, therapy mode changes were logged during the corresponding event.From this we can conclude that other ventilation modes were possible, contrary to the user's description.The exact root cause could not be identified.The device was successfully tested on site in accordance with the manufacturer's specifications and put back into operation.

• Brand Name: ATLAN A350
• Type of Device: 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: 17867341
• MDR Text Key: 324873141
• Report Number: 9611500-2023-00346
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 04048675556176
• UDI-Public: (01)04048675556176(11)210729(93)8621500-11
• Combination Product (y/n): N
• PMA/PMN Number: K230931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1