MAUDE Adverse Event Report: MERITS HEALTH PRODUCTS CO.,LTD MERITS HEALTH PRODUCTS; AVID VECTOR REHAB CHAIR

Model Number	P323
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We received the problem description of medwatch report and related photos from the importer.The device was yet not returned back.Base on the provided serial number, the final inspection report of this specific device was reviewed and the device did comply with our quality criteria.Based on the provided photos, the possible reason of this event might be that the footplate length was set at the lowest position and the user did not raise up the power footplate to ensure enough ground clearance when riding from the sidewalk to the pavement.Base on the provided information, the user did not use the safety belt at that time.This has caused him fell out the chair when this event happened.In order to ensure that the user is very clearly aware that they need to pay attention to ensure enough ground clearance, we will update our owner's manual and add additional warning label.(see appendix iv) if the device is returned for further investigation, in case there is any addition action required, we will submit follow up report.(b)(4).
Event or Problem Description
The patient claimed the footplate dropped down and caught on the concrete which caused him to flip out of his chair sustaining injuries.The patient was apparently not wearing his seat belt and upon examination of the footplate it had been adjusted to lengthen it which lessened the ground clearance.The dealer reported that he went to the doctor the next day and they just gave him instructions on how to attend to his scrapes.Patient now claims that he has headaches and needs plastic surgery for his nose.He is seeking compensation.The dealer is unwilling to send the medical records to us due to hippa regulations.Footplate was replaced by dealer and patient is currently using chair.

• Brand Name: MERITS HEALTH PRODUCTS
• Common Device Name: AVID VECTOR REHAB CHAIR
• Manufacturer (Section D): MERITS HEALTH PRODUCTS CO.,LTD; no. 18. jingke rd,tpmt park,; nantun district,; taichung city, 40852 ; TW 40852
• MDR Report Key: 8752687
• Report Number: 1000221992-2019-00001
• Device Sequence Number: 16643951
• Product Code: ITI
• UDI-Device Identifier: 04714379291698
• UDI-Public: (01)04714379291698
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/07/2019
• Report Date (Section F): 06/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: P323
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/17/2019
• Device Age: 20 MO
• Event Location: Other
• Date Report to Manufacturer: 06/08/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 95