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

Model Number FLOW-C

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/24/2022

Event Type  malfunction  

Event Description

It was reported that an increase in o2 concentration occurred on the anesthesia workstation.There was no patient harm.Manufacturer's ref.#: (b)(4).

Manufacturer Narrative

It was reported that an increase in o2 concentration occurred on the anesthesia workstation.Based on the information collected to date, the provided problem description and the inspection of the device conducted by the technician, it has been clarified that the claimed difference between supplied and set oxygen concentration could not be reproduced on-site.The occurrence of the issue could be confirmed by provided photo.In the photo date of the event 24th november, 2022 was shown.The issue cannot be confirmed in provided device's logs as no log post from this date are available.The customer contacted gas supply service party to check the efficiency of the installation.No issues have been found at the supply gas site.The issue has been analyzed by clinical specialist.The main conclusions are that there was a leak in the circuit and in pressure control ventilation settings, this can lead to that during the inspiration phase, more than the expired gas from the patient allowing for partial re-administration is entering the breathing circuit.The volume reflector stores the expired gas from the patient allowing for partial re-administration of the gas to the patient through the circle system.During the inspiration phase reflector gas (which is oxygen) from the reflector gas module will be routed into the other end of the reflector gas channel and like a piston push the expiratory gas out from the reflector and through the co2 absorber.The fresh gas flow can be set to more than inspiratory minute volume to ensure leakage compensation from fresh gas side, this way reflector gas (o2) will not leak into circuit.The breathing circuit used during claimed issue has not been obtained.The root cause to the reported issue has not been determined.The correction of fields #b3 date of event, #g3 date received by manufacturer, #h4 device manufacture date and #h8 usage of device was required.This is based on the internal evaluation.#b3 date of event: previous date of event: 02/08/2023, corrected date of event: 11/24/2022.#g3 date received by manufacturer: previous date received by manufacturer: 02/08/2023, corrected date received by manufacturer: 01/31/2023.#h4 manufacture date: previous manufacture date: 05/24/2019, corrected manufacture date: 05/14/2019.#h8 usage of device: previous usage of device: unknown, corrected usage of device: reuse.

Event Description

Manufacturer's ref.#: (b)(4).

• Brand Name: FLOW-C
• 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: 16502335
• MDR Text Key: 310876214
• Report Number: 8010042-2023-00499
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FLOW-C
• Device Catalogue Number: 6887700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1