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

Model Number FLOW-I C20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2020

Event Type  Injury  

Event Description

It was reported that the anesthesia workstation was used during an emergency trach.Procedure and the patient coded during the procedure.The patient was put on a ventilator after.The patient final outcome is unknown.Manufacturer's reference #: (b)(4).

Manufacturer Narrative

The anesthesia system was investigated at the hospital by our field service engineer.The investigation did not reveal any issues that can be traced to the reported event.The device logs were saved and sent for evaluation.A tracheostomy was performed due to a high airway obstruction, swelling, bleeding in the airway above the vocal cords or because the patient had been treated on a ventilator for a long time.Regardless of whether it was a primary emergency installation of a tracheostomy (i.E without endotracheal tube) or a change from endotracheal tube to tracheostomy, these interventions are associated with big leakages around the airway.This can be confirmed in the logs.Our conclusion is that there was no device malfunction and ventilation issues found in the log were most likely caused by leakage due to the type of procedure that was performed which created leakages.

Event Description

Manufacturer's reference number: (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: 10162254
• MDR Text Key: 195388483
• Report Number: 3013876692-2020-00031
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: Yes
• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/16/2024
• Distributor Facility Aware Date: 04/09/2024
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/16/2024
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening