MAUDE Adverse Event Report: DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. TRSX58FBP; MECHANICAL WHEELCHAIR

Model Number TRSX58FBP

Device Problems Device Tipped Over (2589); Mechanics Altered (2984)

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

Event Type  malfunction  

Manufacturer Narrative

S/n (b)(4), lot 3029686-235,ship out on 05/14/2015.Check the inventory in warehouse and from customer side ,no stock found.Check this lot production, the wheelchair was shipped without footrest, the alleged footrest was equipped by end user, end user advised to choose footrest accord to personal desire.Performed parking test ,for this model wheelchair ,passed test, friction was adequate to hold the wheelchair.The wheelchair tip forward with end user in it, performed stability test, passed the test, this was due to end user improper use of device.According to user manual p19, do not shift your weight or sitting position toward direction you are reaching as the wheelchair may tip over ,and forward positon the front casters so that they are extended as far forward as possible and engage wheel locks.End user advised to read user manual before using device ,and suggest the end user not use device on too slippery surface.

Event Description

End user is stating that the leg extenders are to short, with a broken ankle and knee she needs her leg to remain straight.End user is also stating that the leg extenders don't stay in place.Sometimes the wheels just spins and she can't get traction.The chair has been known to tip forward with her in it.

• Brand Name: TRSX58FBP
• 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: 6019596
• MDR Text Key: 57472784
• Report Number: 3004766495-2016-00002
• 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: Patient
• Type of Report: Initial
• Report Date: 10/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TRSX58FBP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/28/2016
• Initial Date FDA Received: 10/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2015
• 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