MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB FLOW-I; GAS-MACHINE, ANESTHESIA

Model Number FLOW-I C20

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that water orginating from the compressed air supply was found in the air gas module.There was no patient connected to the anesthesia workstation during the event.Manufacturer´s ref #: (b)(4).

Manufacturer Narrative

It was reported that water was found when the compressed air supply pipeline was pulled out.When the machine was dismantled on site, a large amount of water was found in the air module.The reason was that there was condensed water in the compressed air supply pipeline, which caused water to enter the anesthesia machine and damage the air module.No parts were returned for investigation and no device logs were provided.Our conclusion is that the compressed air supplied to the anesthesia workstation contained too much water.(b)(4).

Event Description

Manufacturer´s ref #: (b)(4).

• Brand Name: FLOW-I
• Type of Device: GAS-MACHINE, ANESTHESIA
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 8973858
• MDR Text Key: 156899827
• Report Number: 8010042-2019-00669
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• PMA/PMN Number: K160665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1