MAUDE Adverse Event Report: JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD INVACARE TRACER EX2 WHEELCHAIR WITH REMOVABLE DESK-LENGTH ARMS, 18" X 16"; WHEELCHAIR, MECHANICAL

Model Number TREX28RP

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hip Fracture (2349)

Event Date 12/16/2018

Event Type  Injury  

Manufacturer Narrative

The (b)(6) representative advised that at the time of the incident, the patient was self-propelling the chair with her legs.The patient did not engage the wheel locks and she tried to get up, and the chair went out from under her when she used the arm rests to lift herself.The (b)(6) representative advised that the patient is a fall risk, so she is supposed to have constant watch.There was no alleged malfunction or defect with the chair.The reported fall and subsequent injury were a result of the user not following proper procedure.The tracer ex2 wheelchair user manual advises to "always use the handrims for self-propulsion." it also states that before attempting to transfer in or out of the wheelchair, be certain the wheel locks are engaged to help prevent the wheels from moving.Following these instructions mitigates the risk of an adverse event occurring.

Event Description

Invacare received a medwatch report from (b)(6) alleging that the patient was in her trex28rp wheelchair trying to self-propel back to her room, and she raised herself up to a partial standing position by using the wheelchair's armrests.At that time, the wheelchair moved, the patient fell onto the floor on her buttocks, and she hit her head on the floor.The facility staff called 911, and the patient was taken to the hospital.While at the hospital, a ct scan of the patient's head and hip was performed, which showed a fracture of the right hip.They advised that the hip fracture was minor and did not require surgical intervention.The patient was later discharged to the skilled nursing facility for physical therapy/rehab.

• Brand Name: INVACARE TRACER EX2 WHEELCHAIR WITH REMOVABLE DESK-LENGTH ARMS, 18" X 16"
• Type of Device: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD; no.36 danyan road; danyang city, jiangsu 21230 0; CH 212300
• MDR Report Key: 8335388
• MDR Text Key: 136036364
• Report Number: 1531186-2019-00002
• 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
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/13/2019,01/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: TREX28RP
• Device Catalogue Number: TREX28RP
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2019
• Distributor Facility Aware Date: 01/21/2019
• Device Age: 2 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/13/2019
• Date Device Manufactured: 08/01/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 68