MAUDE Adverse Event Report: DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935; MECHANICAL WHEELCHAIR

Model Number V16RFR

Device Problems Material Disintegration (1177); Device Tipped Over (2589)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

S/n (b)(4), lot 3016113-214, ship out on (b)(6) 2012.Check the inventory in warehouse and from customer side, no stock.Check dhr of this lot production, no this nonconformity record.This production was in use for 3 years, and from adverse event file report, mentioned that the facility didn't maintain the wheelchair properly.User manual specified: adjust front casters/forks bearing system if wheel wobbles noticeably or bind to a stop.Advice maintaining wheelchair according to manual ,avoid malfunction happen.Not return.

Event Description

The maintenance director at the facility that the end user lives called and stated that the fork stem bearings on the right fork have disintegrated.The caller states that the end user is the second user of this chair.The caller also states that when the bearings disintegrated and fell out, the fork fell off and the chair tipped over with the end user in the chair and she fell and fractured her right shoulder.The caller stated that the end user received x-rays, but he was not sure they did it in house or took her to the hospital.The facilities administrator provided end user information.The facilities administrator stated they were cited by the state for a deficiency due to this incident and needs to check with the facilities operations to see how long they need to keep the chair in house.No other information available.

• Brand Name: 16 IN X 16 IN FRAME W/DESK LNGTH RMOV ARMS AND ELEV FTRST 9153651935
• Type of Device: MECHANICAL WHEELCHAIR
• Manufacturer (Section D): DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.; 36 danyan rd.; danyang, jiangsu 21230 0; CH 212300
• Manufacturer (Section G): DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD.; 36 danyan rd.; danyang, jiangsu 21230 0; CH 212300
• Manufacturer Contact: yao wenbin ; 36 danyan rd.; danyang, jiangsu 21230-0 ; CH 212300 ; 5118619700
• MDR Report Key: 6143810
• MDR Text Key: 61402374
• Report Number: 3004766495-2016-00007
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: V16RFR
• Device Lot Number: 3016113-214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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
• Patient Outcome(s): Other