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

Model Number FLOW-I C20

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

It was reported that the hospital was cleaning and disinfecting the oxygen and air piping system.The anesthesia workstation was not disconnect from the air and oxygen supply in advance before filling the system with disinfectant liquid.The anesthesia workstation failed the system checkout.There was no patient harm reported.Manufacturer's ref.#: (b)(4).

Event Description

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

Manufacturer Narrative

The investigation has been finalized.According to the information provided by the technician, the gas modules have been replaced and the issue has been solved.The device passed all performance tests and could be returned to clinical use.Moisture in a gas module as previous investigation has shown may affect the electronic inside the gas module.According to the users' manual, maximum levels of water, (h2o < 7 g/m3) in the supplied gases to the ventilator must not be exceeded.The gas module regulate the gas flow and a fault in the gas module may lead to inaccurate gas flow regulation.This will be detected during system checkout and alarms will be activated if the failure occurs during treatment.The issue has been assessed as usability related, the user did not disconnect the supply hoses before cleaning maintenance was performed.Why the user did not disconnect before cleaning has not been determined.The correction of field #h8 usage of device was required.This is based on the internal evaluation.#h8 usage of device: previous usage of device: unknown.Corrected usage of device: reuse.

• 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: 15578780
• MDR Text Key: 304834512
• Report Number: 8010042-2022-01773
• Device Sequence Number: 1
• Product Code: BSZ
• Combination Product (y/n): N
• Reporter Country Code: RS
• PMA/PMN Number: K191027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

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: 09/25/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/13/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1