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

Model Number FLOW-I C20

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

It was reported that the co2 absorber bypass valves came loose on the anesthesia system.There was no patient harm.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

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 initially claimed issue with absorber valves, has been loose connection to the patient cassette.The user replaced malfunctioning cassette with other one to use the unit without issues.The user refitted loosen valves into cassette.No other failures have been reported.Loose absorber bypass valves may lead to stop of ventilation without possibility to use the built-in emergency ventilation.Per design, alarms will be generated.The root cause why absorber valves came loose has not been determined.The correction of fields #h4 device manufacture date and #h8 usage of device was required.This is based on the internal evaluation.#h4 manufacture date: previous manufacture date: 10/16/2020 corrected manufacture date: 09/05/2020.#h8 usage of device: previous usage of device: unknown corrected usage of device: reuse.

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: 15216089
• MDR Text Key: 304589569
• Report Number: 8010042-2022-01384
• Device Sequence Number: 1
• Product Code: BSZ
• UDI-Device Identifier: 07325710001349
• UDI-Public: (01)07325710001349(11)200925
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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 Model Number: FLOW-I C20
• Device Catalogue Number: 6677200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/12/2022
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1