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

Model Number MODUTEC

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 04/27/2017

Event Type  malfunction  

Manufacturer Narrative

The initial investigation has been done together with field service engineer as following.- customer stated that the end beam cover fell off after being hit, rather than a normal use.As checked, this unit was manufactured and delivered in year 2009, and there was no any feedback received regarding this unit in the past years, therefore we could believe it¿s in a normal condition as intended until this issue happened.- as review of the complaint history, there are a few similar cases happened since launch of this product modutec.Refer to the investigation results, these reported cases are all caused by hitting/collision with other equipment during positioning the device which are concluded as use error since the design of the end cover is demonstrated compliance with iec 60601-1 by design verification, and additionally a warning is included in user manual to remind the customer to avoid collision when moving devices.With the above information, we can indicate this complaint case is also very likely caused by use error- careless during positioning of the device which resulting in the hitting between devices.Customer decided to order a spare part of end cover to fix the issue.Maquet field service engineer is scheduling a visit with customer to seek more information and provide the support for fixing the issue.A follow-up report will be submitted when additional information becomes available.

Event Description

On (b)(6) 2017, a hospital in usa reported that the beam end cover of the modutec fell off after being hit.No injury was reported.(b)(4).

Manufacturer Narrative

According to further communication with the customer, it is specified that: the beam end cover was hit by the surgical light when they moved the surgical light close to the bed.That is the reason which made the beam end cover be loose and fall off finally.With above information, it proves that this complaint was caused by use error- careless during positioning of the device which resulting in the hitting between devices.

Event Description

(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: 6581370
• MDR Text Key: 75857722
• Report Number: 3007417753-2017-00002
• 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,Followup
• Report Date: 06/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2017
• 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: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2009
• 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