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

Model Number MODUEVO-PLGII

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

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Updated a2 and f10/h6, and information of patient is not available.

Event Description

On aug 15th., 2023, getinge brazil received a complaint from a hospital in brazil that ceiling cover fell down and hit the table clamp with the patient in use during surgery.There were no injuries to the patient or user.

Manufacturer Narrative

The investigation has been started since the complaint (ot#(b)(4)) was received, the following contents have been conducted: 1).Investigation at hospital.A.Getinge brazil field service engineer visited the hospital as planned, it¿s clarified with the hospital staff that the reported ceiling cover is in good condition, not any broken.No any injury was reported.B.The ceiling cover has been re-installed by hospital directly after incident, and the pendant had been released for clinical use.Fse checked the pendant status, there is no any abnormal indicated, based on the situation, fse state no further investigation could be performed.C.Fse checked other all ceiling cover of this hospital, no similar problem was observed.2) investigation at getinge suzhou.A.The dhr(device history record) of the pendant was reviewed, no material or manufacture abnormality relevant to ceiling cover was observed.B.The complaint history record has been reviewed and no feedback relevant to the reported pendant during installation or use was received.C.The pedant was designed and evaluated according to iec 60601-1 requirements.The design of ceiling cover was demonstrated robust from the verification test result.D.The ifu(instructions for use) of moduevo (ifu 009001001 en 12 2022-12-20), point 7.3 ¿ inspection & maintenance¿ message has stated that ¿ in order to ensure the operational safety of the product, an inspection must be carried out annually in accordance with the generally recognized rules of technology.The inspection includes technical safety checks as well as any lubrication of the product.The inspection is to be carried out by specialist personnel who, on account of their education, knowledge and experiences gained from practical activities, are capable of correctly executing the technical safety checks.For the execution of the inspection, technical information is available from getinge on request.To ensure availability of all functions as well as an increased service life, getinge recommends concluding a maintenance contract.Getinge offers maintenance services at different levels.Maintenance may only be performed by getinge service or service technicians that have been authorized by getinge.Maintenance must be performed every 2.5 years' in maintenance message.¿however, it seems the instruction was not fully followed in this case, based on communication with fse, the hospital had not carried out preventive maintenance in recent 4 years.According to the above investigation, there¿s no deficiency identified from production relevant to the ceiling cover falling down.The communication with fse indicated the most probable root cause is poor maintenance due to negligence of following ifu, which caused ceiling cover falling down.This is the first incident reported from the field, which is believed to be an isolated case, the trending of the reported issue will be monitored continuously.

Event Description

On aug 15th., 2023, getinge brazil received a complaint from a hospital in brazil that ceiling cover fell down and hit the table clamp with the patient in use during surgery.There were no injuries to the patient or user.

• 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: 17629812
• MDR Text Key: 322023696
• Report Number: 3007417753-2023-00004
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODUEVO-PLGII
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 7010012052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1