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

Catalog Number 8621500

Device Problems Failure to Deliver (2338); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/04/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still on-going.The results will be provided with a follow-up report.

Event Description

It was reported that the machine malfunctioned during induction.The patient could not be ventilated and it felt like a huge leak.No injury reported.

Manufacturer Narrative

Log analysis for the date in question has shown that just from the beginning "apnea, minute volume low, tidal volumen not achieved" alarms were posted.Besides this entries indicating fluctuating inspiratory/ exspiratory flows, differences between inspiratory and expiratory flows, fluctuating pressure values and fluctuationg inspiratory and expiratory co2 values were found in the log.As no hint for a technical root cause could be identified it is assumed that the fluctuating values were caused by patient breathing activity or patient repositioning during induction.A leakage test was performed some days after the event without detection of any significant leakage.Finally, no hint for a device malfunction has been found.The device has reacted on the detected situation as specified by posting corresponding alarms to inform the user about the situation.

Event Description

It was reported that the machine malfunctioned during induction.The patient could not be ventilated and it felt like a huge leak.No injury 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: 18289124
• MDR Text Key: 329997406
• Report Number: 9611500-2023-00459
• 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,Followup
• Report Date: 02/19/2024

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 Catalogue Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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