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

Model Number FLOW-I C20

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Event Description

It was reported that there was a leakage of anesthetics agent from the bottom of the vaporizer.There was no harm reported.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that there was a leakage of anesthetic agent from the bottom of the sevoflurane vaporizer.A video that was received from the local distributor showing the leakage confirms the reported issue.According to received information, the user did not want the to send the vaporizer for repair.No logs have been available to confirm any alarms or technical error codes related to the reported event.Based on the limited information in this complaint, we are not able to determine the true cause of the leakage.H3 other text : 4114.

Event Description

Manufacturer's reference #: (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): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: caroline kabbabe ; roentgenvagen 2; solna
• MDR Report Key: 16331435
• MDR Text Key: 309125690
• Report Number: 8010042-2023-00291
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/28/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1