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

Model Number MODUTEC

Device Problems Break (1069); Component Falling (1105)

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

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

After receiving this complaint, a maquet fst (field service technician) visited this hospital and evaluated this device.It's confirmed that there was only a laptop on the itd swivel shelf when it was falling down.The laptop is still working after the itd swivel shelf fell down to the floor, no person is hit and no injury is reported.Maquet (b)(4) conducted following initial investigation after receiving the complaint dhr of this concerned ceiling supply unit(csu) was reviewed.This unit was produced in may of 2013, the dhr showed no any deviation identified from the manufacturing process and final release testing.Complaint historic data about this concerned unit was reviewed.Since this unit was delivered in may of 2013, there was no any feedback received during installation and after released to end user until now.Complaint historic data was also reviewed for any similar case reported in the past.Around 700 units itd swivel shelves have been configurated with csus and delivered since year 2008.Till now two similar complaints were received - one was this case, another was reported recently on 2016-06-17 from usa market ((b)(4)).The further communication and investigation of that case is ongoing.Maquet (b)(4) has sent new adaptor plate to fst for replacement, and is requesting the defective sample back for further investigation.A follow-up report will be submitted when it's done.

Event Description

On 2016-05-13, maquet (b)(4) received a complaint from one hospital in (b)(6) that the adaptor plate of itd swivel shelf mounted on one unit of ceiling supply unit, modutec was broken, which was delivered on (b)(6) 2013.Per field service technician's further investigation on 2016-06-03, it's aware that this itd swivel shelf with broken adaptor plate fell off during use, and no person was hit.No injury or death was reported.(b)(4).

Manufacturer Narrative

This concerned swivel shelf is designed and produced by (b)(4), (b)(4) just fix it to our ceiling supply unit.The defective sample was returned back to itd for analysis and investigation.Here is the investigation summary from itd: - the design of the swivel shelf was reviewed, and it passed 6x safety factors (total 90kg) load test according to en 60601-1 and also passed life-cycle test (20000 cycles) under max load to simulate 10 years' use.So the swivel shelf could be used safely per normal use.- per appearance analysis of the defective sample, the broken condition (e.G.Cracking area, angle) of the defective sample shows that it was deformed and cracked upwards.Similar test regarding an upwards force was done by itd, and adaptor plate was broken by a upwards direct force with 182,5nm.The sample analysis result matches the test result, so this adaptor plate was damaged by a upwards direct force during use.In view of itd swivel shelf's intended use, itd swivel shelf is used for carrying and positioning objects, and it does not take into consideration the upwards force.According to above information, it's concluded that the concerned swivel shelf was broken due to unexpected activities that the swivel shelf was collided from upwards and led to a broken of the adaptor plate finally.Exemption (b)(4).

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: 5765238
• MDR Text Key: 49382370
• Report Number: 3007417753-2016-00001
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• 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: 06/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• 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