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

Catalog Number 8621500

Device Problem Use of Device Problem (1670)

Patient Problem Cardiac Arrest (1762)

Event Date 01/23/2024

Event Type  Death  

Manufacturer Narrative

The device was successfully tested and calibrated on site without finding any deviation from specification.The device log was provided for investigation.It could be comprehended based on the records that the device was continuously in operation mode on the date of the reported event january 23rd 2024 from 10:27am to 05:56pm.It was reported that the case in question took place between 11:00am and 3:00pm and that any entries outside of this time frame belongs to other patients and can be ignored.Nevertheless, the log evaluation was conducted for the whole operation time.The device log file was analyzed in-depth without finding any indication of a technical malfunction being related to the reported patient outcome.Reportedly, the user had problems to configure alarm limits.The configuration of alarm limits is described in the instructions for use in chapters "checking device configuration" and "alarm limits".After the case in question the used had been informed by the local dräger team about the right way to configure and save alarms settings.Finally, no device failure had been found.Based on the information available, it is not possible to make a statement whether an use error contributed to the reported patient outcome.

Event Description

It was reported that the patient suffered a cardiac arrest while connected to our device.The patient was transferred to the icu and passed away.

• 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: 18667013
• MDR Text Key: 334845073
• Report Number: 9611500-2024-00045
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K0230931
• 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
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 8621500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death