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

Catalog Number 8621300

Device Problem Gas Output Problem (1266)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be forwarded when the investigation was closed.H3 other text : on-going.

Event Description

It was reported that the equipment stopped ventilating, displaying a fan failure message.No injury was 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: 19123838
• MDR Text Key: 340351838
• Report Number: 9611500-2024-00165
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 040868555634
• UDI-Public: (01)040868555634(11)220330(93)8621300-13
• 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
• Report Date: 04/17/2024

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 Operator: Health Professional
• Device Catalogue Number: 8621300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/30/2022
• 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