MAUDE Adverse Event Report: HELENA LU MAQUET; TUBING, PRESSURE AND ACCESSORIES

Model Number MODUTEC

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation has been done together with maquet service us as following.- customer stated that the end beam cover fell off after being hit by other equipment in the room, rather than a normal use.As checked, this unit was manufactured and delivered in year 2010, and there was no any feedback regarding the end beam cover connection during installation or previous maintenance.Therefore, we could believe it¿s in a normal condition as intended until this issue happened.- the design of the end beam cover is demonstrated compliance with (b)(4) by design verification, and additionally a warning 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.With the above information, we can indicate this complaint case is caused by use error- careless during positioning of the device which resulting in the hitting between devices.Maquet service us had replaced the broken end beam cover, adjusted the stops on the modutec and instructed the customer on the proper use of the modutec to help avoid collisions.

Event Description

On jun 08, 2017, the hospital staff told maquet service us that the beam end cover of the modutec fell off after being hit, and the exact event date was unknown.No injury was reported.(b)(4).

• Brand Name: MAQUET
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• Manufacturer (Section G): HELENA LU; maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502 4; CH 215024
• Manufacturer Contact: maquet (suzhou) co., ltd; no.158, fang zhou rd. suzhou; suzhou 21502-4
• MDR Report Key: 6669376
• MDR Text Key: 78587049
• Report Number: 3007417753-2017-00003
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODUTEC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1