MAUDE Adverse Event Report: MAQUET (SUZHOU) CO.,LTD. MODUEVO; TUBING, PRESSURE AND ACCESSORIES

Model Number MODUEVO-MA

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

On (b))(6) 2023, getinge switzerland received a complaint from the hospital in switzerland that a low o2 flow rate during the intubation for patient.The o2 gas is delivered through the gas source in the hospital, gas pipeline within medical ceiling supply units then enters into the ventilator.The doctor replaced all the equipment which probably contributed to low o2 flow, including medical ceiling supply unit, ventilator and so on, then the o2 flow became normal, the procedure was continued.No injury or death was reported.

Manufacturer Narrative

(b))(4).Preliminary investigation is as following: the doctor replaced all the equipment which probably contributed to low o2 flow, including medical ceiling supply unit, ventilator and so on, then the o2 flow became normal, the procedure was continued.The concerned unit was put on hold and not used currently.This is the first incident we received since the initial product launch in year 2016, there is no similar case or investigation could be referenced.Getinge service engineer has visited the hospital when the claim was received, and performed an initial inspection on the involved unit, no leakage or other issue was found.A further visit and the further verification on the involved unit will be arranged.Maquet suzhou is collecting more information to proceed the further investigation, the result will be provided in follow-up/final report.

Manufacturer Narrative

Product introduction: the medical ceiling supply unit (model: moduevo )is made up of a number of modules that can be configured with one another.Depending on the modules used, medical ceiling supply units are designed for the following purposes: ¿ carrying and positioning of medical devices and monitors ¿ supply with mains voltage, compressed air and medical gases ¿ aspiration of anaesthesia gases and compressed air in line with the intended purpose, moduevo is produced and assembled into the several modules such as beam, distributor at manufacturing site, distributed to the healthcare facility then installed together and connected with the gas supply and electricity of healthcare facility.The installation and connection is completed on site of healthcare facility.When received the incident from customer side, getinge switzerland service engineer visited the hospital at once for confirmation of the incident, and performed initial inspection as following: 1) service engineer performed flow test of reported moduevo with flow meter, he observed the pressure dropped more than expected at the defined input flow rate, which was similar with what customer reported.2) service engineer inspected the involved moduevo product completely, no leakage or damage was observed at all gas pipeline connections, no trap was observed on the gas hoses, and no any other abnormal issue which probably block the air flow was found.For further inspection, service engineer cut off the concerned o2 hose to check the inner of the hose.Finally, a small part of plastic foreign matter was found nearby the branch joint of gas pipeline, which was right on the path of the airflow and deemed very likely to cause the reported issue.3) service engineer removed this small plastic part, replaced the cut hose with a new one and reconnected the gas pipeline, then tested the air flow and other gas pipeline functions, all tests passed.Thus the reported device was verified fully operational as expected and released to use.4) additionally, getinge service engineer checked all moduevo products in the same hospital with flow meter, no similar problem was identified.Getinge service engineer reported all the above to maquet suzhou for further investigation.Suzhou investigation team firstly organized the review on the history record and data of the reported moduevo to see if there is any potential issue occoured during manufacturing,installation and after putting in use.1).Review the manufacturing record as checked, the reported moduevo was produced in oct.2020.The production history record including all the tests on gas pipeline was reviewed and found: - obstruction test for all types of gas hose passed; - all types of gas outlets and labeling verified correct; - color and marking of gas hoses verified correct; - leakage and integrity tests passed; as above, no deviation was identified from the production process, the concerned moduevo product passed all the inspection and testing before release.2) review the installation record as verified, this moduevo was installed in the hospital "chuv " in apr.2021 by getinge witzerland service engineer.A) getinge service engineer confirmed that the defined method and requirements in the installation manual were fully followed, and the relevant inspection was conducted after installation, which showed the unit was in good condition.B) meantime, the installation manual requires to do gas check after gas connection including obstruction test, flow rate test, etc according to standard iso7396.(installation manual #009101001 en ed1, page26, section 3.3 requires "the final acceptance tests must be executed by qualified specialist companies in accordance with procedures applicable in the country of use.).The gas pipeline test report from customer showed the gas pipeline check was performed by a third party as designated on june 2022.It could be found the obstruction flow test on the gas distribution system medical oxygen was performed as following: (refer to attachment 02 for details) - test condition of obstruction & flow test in standard iso7396: specified flow rate 40.0 l/min.- acceptance criteria: specified pressure change max.0.4 bar (10%).- test result: the actual pressure change is 0.1bar, less than 0.4bar, so result is pass.As above, the reported moduevo product was verified acceptable after installation, including the air flow rate of o2 gas pipeline.3)review the complaint history the complaint history record of the concerned unit has been reviewed.For the reported moduevo, there was no claim received in the past years after putting in use, until this complaint was received.The overall complaint data of moduevo product family has been reviewed.Until now over 20000 units moduevo have been delivered to market since initial launch in oct.2016, this is the only complaint regarding low gas flow rate.No similar claim was received so far.In summary, the above records review showed the involved moduevo passed all the production inspection and test before release for shipment, which demonstrated no deficiency relevant to the low o2 flow rate identified from manufacturing process.The initial testing after installation and the history of complaints showed the unit has been working at normal air flow in the past months until the issue was observed and reported.In parallel to the record review, maquet suzhou investigation team focused on analysis of the small plastic part found from inner of the o2 gas hose as it's deemed as the cause of low air flow rate.1) what is the plastic part? - from the picture taken by service engineer(attachment 01), this part is made from a kind of translucence plastic.It's obviously not a material apart from the gas hose, or gas terminal outlets or any other part of moduevo as their materials are very different from this translucence plastic.There is also no similar material used in the production line at maquet suzhou and during the installation process.The investigation team requested to return the plastic part for further analysis, but unfortunately it's discarded by customer and not available for further chemical analysis.2) why is this part not found at the beginning of use, but after the product has been used for over years? - as measured, the size of the plastic part is around 4.5 mm, less than the inner diameter of gas hose(around 6.3mm).When it enters into the gas hose, it does not impact the air flow obviously as it's smaller than the hose.But slowly pushed with the pressure of gas flow, it's finally moved to nearby the branch joint( the inner diameter of joint is around 4mm) and caused the low air flow.3) where does the plastic part come and how does it enter the o2 hose? - the overall gas pipeline system contain the gas supply system in the hospital, the gas hose and gas terminal units assembled with moduevo.The gas is supplied from the source of the hospital then flow to the gas terminal outlet in order to support the other devices.According to all available information, there is no indication where the small plastic part is from and how it enters the hose.The review on the manufacture process, installation process and customer gas check all indicated normal before releasing for clinical use.In summary, base on the above investigation, the low flow rate is deemed caused by the small plastic part nearby the gas pipeline branch joint.However, the source of the small plastic part could not determined.Results of the risk assessment: the risk analysis of medical ceiling supply unit moduevo (document id: risk analysis_csu_moduevo_v08 release date: 2023-05-31) has been reviewed, the risk for o2 low flow is determined as below.Severity: ¿impairment or injury¿ rated as ¿s3¿; occurrence: ¿improbable - harm is not likely¿rated as ¿p1¿.The risk analysis document is considered properly reflecting the status of the occurred event, and not necessary to be revised.Remedial action: 1.The doctor replaced all the equipments which probably contributed to low o2 flow, including medical ceiling supply unit, ventilator and so on, then the o2 flow became normal, the procedure was continued.The concerned unit was put on hold and not used until reporting of this event.(action is completed in oct-2023) 2.Getinge service engineer repaired the reported device by replacement of gas hose, and verify it could operate as expected and then release it for use.(action is completed in nov-2023) 3.All moduveo in the same hospital have been checked and confirmed no similar issue existed.(action is completed in nov-2023).

Event Description

On oct 3rd., 2023, getinge switzerland received a complaint from the hospital in switzerland that a low o2 flow rate during the intubation for patient.The o2 gas is delivered through the gas source in the hospital, gas pipeline within medical ceiling supply units then enters into the ventilator.The doctor replaced all the equipment which probably contributed to low o2 flow, including medical ceiling supply unit, ventilator and so on, then the o2 flow became normal, the procedure was continued.No injury or death was reported.

• Brand Name: MODUEVO
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section G): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• Manufacturer Contact: lu helena ; no.158 fang zhou road; suzhou industrial park; suzhou
• MDR Report Key: 18054059
• MDR Text Key: 327135738
• Report Number: 3007417753-2023-00005
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODUEVO-MA
• Device Catalogue Number: D064037
• Device Lot Number: 7010016032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/29/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female