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); Intermittent Communication Failure (4038)

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

Event Date 10/08/2023

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 ventilator failure alarm occurred during the operation and no health consequences have reportedly occurred.

Manufacturer Narrative

It was reported that the ventilator failure alarm occurred during the operation, then the connector pcb was replaced, the fault was solved, and the machine test ran normally.No patient injury.The faulty parts were received in sdmi, but it was found that one capacitor was fallen, it belonged to the expiratory pressure sensor on the pba connectorboard.Contacted to the service engineer, he remembered the capacitor was still on the exp.Pressure sensor pcb when he disassembled the faulty board.The capacitor is not the crucial element that leads to the failure, the main function is to store energy to prevent the voltage of both ends of the circuit changing abruptly.The investigation and multiple tests have been performed based on the replaced part , no failure could be reproduced.It could be a random case that may be caused by some improper connection of some electronic circuit of the ventilating system.Keep monitoring.

Event Description

It was reported that ventilator failure alarm occurred during the operation and 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: 18109402
• MDR Text Key: 328657384
• Report Number: 3019545235-2023-00016
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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