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

Model Number MODUTEC

Device Problem Break (1069)

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

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

After receiving this complaint, a maquet stm (service territory manager) visited this hospital and evaluated this device.It's confirmed that: this concerned itd swivel shelf was ordered individually and installed by a maquet installer on the ceiling supply unit (csu), modutec later on.Hospital staff normally use this itd swivel shelf to load iv bag, paperwork and hoses which are about 2 pounds.Staffs were not in the room when the itd swivel shelf fell to the floor.No person is hit and no injury is reported.Maquet (b)(4) conducted following initial investigation after receiving the complaint this csu was delivered in nov-y2013 and the concerned itd swivel shelf was delivered in sep-y2015.Dhr and relevant record of this concerned csu and itd swivel shelf were reviewed, no any deviation was identified from the manufacturing process and final release testing.Complaint historic data about this concerned csu and itd swivel shelf were reviewed.Since this itd swivel shelf was delivered in sep-y2015 and installed on this csu, 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 (b)(4) 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 2016-06-03 from belgium market (ref no.(b)(4)).The further communication and investigation of that case is ongoing.Maquet (b)(4) has sent an new itd swivel shelf to stm 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 2016-06-16, customer called maquet us that the itd swivel shelf mounted on one unit of ceiling supply unit, modutec fell to the ground due to a broken adaptor plate.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), maquet suzhou 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 (b)(4): - 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 (b)(4), 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: SWIVEL SHELF
• 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: 5779287
• MDR Text Key: 49912063
• Report Number: 3007417753-2016-00002
• 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: company representative,consum
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• 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
• Device Age: YR
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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