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

Catalog Number 8621500

Device Problems Gas Output Problem (1266); Inaccurate Delivery (2339); Physical Resistance/Sticking (4012)

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

Event Date 01/02/2024

Event Type  malfunction  

Manufacturer Narrative

For the investigation the logfile was analyzed.The described ventilation failure could be retraced in the logfile.It was found during on-site investigation by the service technician that after reprocessing obviously the cleaning disk was not removed from the upper rolling membrane of the piston.Nevertheless, the self-test was passed as the cleaning disk did not cause any leakage or device malfunction.It is assumed that during operation its position changed for example due to movement of the membrane, which caused the ventilation failure.The device alarmed as required by the safety concept and ventilation was continued in man/spont mode.After removing of the foreign material on site the device was successfully tested according to manufacturer's specification.During the manual checklist of the atlan self-test, the correct assembly of the breathing system/rolling membrane etc.Should be checked and the components should also be checked during installation after reprocessing.Therefore, it can be concluded that the event was caused by not following the instructions as described in the ifu.This is the first complaint describing this kind of problem.

Event Description

It was reported that the device failed during operation.Temporary backup ventilation plan was implemented for the remainder of the case.No injury was reported.

• 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: 18864957
• MDR Text Key: 337513952
• Report Number: 9611500-2024-00102
• Device Sequence Number: 1
• Product Code: BSZ
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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