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

Model Number MODUEVO-MA

Device Problem Device Damaged by Another Device (2915)

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

Event Date 01/03/2023

Event Type  malfunction  

Event Description

On jan 3rd., 2023, getinge brazil received a complaint from a hospital in brazil that the iv support arm attached the pendant moduevo ma broken during the night.After getinge field service engineer visited the hospital, it's clarified with the hospital staff that the nurse needed to move the patient bed up , and the bed touched, pushed and forced the iv support arm up, causing a break.This break made the iv pole hit the patient, caused a slight scrape on skin.No medical treatment was given as it's only a skin scrape, and now the patient is fully recovered.

Manufacturer Narrative

The investigation has been started since the complaint (ot#747936) was received, the following contents have been conducted: investigation at hospital : getinge brazil field service engineer visited the hospital as planned, it's clarified with the hospital staff that the nurse needed to move the patient bed up , and the bed touched, pushed and forced the iv support arm up, causing a break.This break made the iv pole hit the patient, caused a slight scrape on skin.No medical treatment was given as it's only a skin scrape, and now the patient is fully recovered.Customer order new iv support arm to replace to solve the problem.Investigation at getinge suzhou: an inspection and analysis was performed on the returned iv support arm as the following.Compared with new iv support arm, it is observed the returned iv support arm is broken and deformed.And from the mechanical structure of design, the deformation looks twisted by the external force from the bottom up, at last caused the arm broken.The material test was performed for the reported iv support arm, the result indicated it meet the standard.The dhr(device history record) of the pendant was reviewed, no material or manufacture abnormality relevant to iv support arm was observed.The complaint history record has been reviewed and no feedback was received relevant to the involved pendant during installation or use.The pedant was designed and evaluated according to iec 60601-1 requirements.The design of iv support arm was demonstrated robust from the verification test result.The ifu(instructions for use) of moduevo (ifu 009001001 en 12 2022-12-20), has stated that ¿care should be taken when moving other medical equipments in the area where ceiling pendant equiped, to avoid damage of accessories( for example shelf and drawer) caused by collision.' in warning message.However, it seems the instruction was not fully followed in this case.According to the above investigation, there¿s no deficiency identified from production relevant to the arm break.The communication with customer indicated the mostly root cause is the collision between bed and moduevo accessories due to negligence of following ifu instructions, which put the abnormal external force to the iv support arm then made it broken.

Event Description

On (b)(6) 2023, getinge brazil received a complaint from a hospital in brazil that the iv support arm attached the pendant moduevo ma broken during the night.After getinge field service engineer visited the hospital, it's clarified with the hospital staff that the nurse needed to move the patient bed up , and the bed touched, pushed and forced the iv support arm up, causing a break.This break made the iv pole hit the patient, caused a slight scrape on skin.No medical treatment was given as it's only a skin scrape, and now the patient is fully recovered.

• Brand Name: MODUEVO
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou
• 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: 16192335
• MDR Text Key: 308934651
• Report Number: 3007417753-2023-00001
• 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: 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUEVO-MA
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 7010016607
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2020
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose