MAUDE Adverse Event Report: SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD. ATLAN A350/A350 XL CC; ANESTHESIA UNITS

Catalog Number 2600000

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

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

Event Date 12/21/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation has just started; results will be provided in a follow-up report.H3 other text : on-going.

Event Description

It was reported that the device had automatically switched from manual mode to standby several times in the past, no health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that ventilator failure during usage, and sometimes the device had automatically switched from manual mode to standby no patient injury reported.After log analysis, two errors and recommendation were given as below.1.2023 (b)(6) 09:43:13 pressure sensor blocked or not connected.This may be caused by a blocked gas supply line, please help by checking that the supply line is properly connected to the negative pressure sensor on the pba board and that the supply line is not bent.2.2023 (b)(6) 09:43:13 incremental encoder error.This fault could lead to malfunction of the motor, and may cause the failure of mechanical ventilation mode.Please perform the ventilator test in the hit software.Attempt to carry out a referencing on the hit page "a350 core unit/ventilator and breathing system/ventilator" from the description of the service engineer, no more actions they have done and no failure reproduced anymore.No more investigation could be done due to lack of more information.The root cause was not confirmed.

Event Description

It was reported that the device had automatically switched from manual mode to standby several times in the past, no health consequences have reportedly occurred.

• Brand Name: ATLAN A350/A350 XL CC
• Type of Device: ANESTHESIA UNITS
• Manufacturer (Section D): SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.; 230 xin jin qiao road; shanghai ; CH
• Manufacturer (Section G): SHANGHAI DRAEGER MEDICAL INSTRUMENT CO. LTD.; 230 xin jin qiao road; shanghai PRC-2 0120; CH PRC-201206
• Manufacturer Contact: 230 xin jin qiao road; shanghai PRC-2-0120 ; 2131086385
• MDR Report Key: 18433833
• MDR Text Key: 331931707
• Report Number: 3019545235-2023-00008
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2600000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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