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

Model Number MODUTEC

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/23/2024

Event Type  malfunction  

Event Description

On (b)(6) 2024, getinge usa received a complaint from the hospital in usa that one beam end cover fell off after being hit by the surgical light in the room.There was no injury reported.

Manufacturer Narrative

The investigation has been started since the complaint (b)(4) was received, the following contents have been conducted: maquet field service engineer (fse) visited the hospital as planned, it's clarified with the hospital staff that the end beam cover fell off after being hit by the surgical light in the room , rather than a normal use.This event occurred during handling the surgical light, the light arm struck the end cover of modutec which caused the cover dislodged and the tether chain broken, then the cover dropped.No one was hit and no any injury was involved.Fse checked the cover and found it¿s in a normal condition, so it's fixed back to the arm and reattached the tether chain to solve the problem.Fse checked the involved modutec furtherly, it shows signs that it has suffered collisions in the past, so the tether chain was broken in this collision.As checked, this unit was manufactured and delivered in year 2015, and there was no any feedback regarding the end beam cover connection during installation or previous maintenance.The design of the end beam cover is demonstrated compliance with iec 60601-1 by design verification, and additionally a warning "care should be taken when rotating the beams, to avoid collisions with personnel or with other equipment" is included in user manual to remind the customer to avoid collision when moving devices.Therefore, the design of the end beam cover was demonstrated robust for normal use.From the above on-site investigation, it could be concluded the root cause is the collision between surgical light and modutec due to the negligence during operation , which put the abnormal external force to the end cover then made it off.Remedial action: maquet field service engineer checked the cover and found it's in a normal condition, so it's fixed back to the arm and reattached the tether chain to solve the problem.H3 other text : not available.

• Brand Name: MODUTEC
• 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: 18927820
• MDR Text Key: 337953157
• Report Number: 3007417753-2024-00001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUTEC
• Device Catalogue Number: D064037
• Device Lot Number: 7010001373
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1