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

Catalog Number 8621500

Device Problems Decrease in Pressure (1490); Inaccurate Delivery (2339); Gas/Air Leak (2946); Pressure Problem (3012)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

It was reported that the customer was unable to pressurise the system in man/spont.Moreover, they still could not get sufficient ventilation pressure in vc mode.

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.

Manufacturer Narrative

Based on the log file analysis the reported event was caused by a large leakage between the inspiratory flow sensor and expiratory flow sensor.Most likely caused by a leak at the breathing circuit or at the patient.The device alarmed for apnea (no flow).The replaced apl valve has been installed on a test system and passed the test.No hint for a device malfunction.A leakage is detected during leak test before use.During use alarms are generated if the device do not reach the set airway pressure and volume limits, as well if the difference between inspiratory and expiratory volume exceeds a limit value or apnea pressure / apnea volume is detected.This case is considered no longer reportable.

Event Description

It was reported that the customer was unable to pressurise the system in man/spont.Moreover, they still could not get sufficient ventilation pressure in vc mode.

• 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: 17570146
• MDR Text Key: 321596465
• Report Number: 9611500-2023-00276
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 09/15/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2022
• 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