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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD INVACARE TRACER SX5 WHEELCHAIR, FLIP-BACK DESK-LENGTH ARMS 16"X16"; WHEELCHAIR, MECHANICAL
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JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD INVACARE TRACER SX5 WHEELCHAIR, FLIP-BACK DESK-LENGTH ARMS 16"X16"; WHEELCHAIR, MECHANICAL Back to Search Results
Model Number TRSX56FBP
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Bone Fracture(s) (1870)
Event Type  Injury  
Manufacturer Narrative
The end user stated that she did not feel that the chair was defective or malfunctioning when the incident occurred.She admitted that she was using the chair to transfer, which caused it to tip over.She advised that when transferring from the chair, she uses the armrests and puts all of her weight on them.She stated that was how the chair was able to flip over on its side when she fell.She indicated that she was previously told not to use the chair to transfer in this way, but she stated that she has no other way to transfer.She was advised of the user manual instructions for transferring which state, "position the wheelchair as close as possible alongside the seat to which you are transferring, with the front casters pointing parallel to it.Remove or flip up the armrest.Engage wheel locks.Swing away or remove front rigging.Shift body weight into seat with transfer.During independent transfer, little or no seat platform will be beneath you.Use a transfer board if at all possible." it also states, "engaging the wheel locks may not prevent the wheelchair from moving on all floor surfaces including those that may be wet or slick.Always exercise caution when transferring into or out of the wheelchair." the end user stated that the wheel locks have been tightened and replaced in the past.She also stated that she has been tightening the wheel lock hardware herself, because it comes loose so often.She indicated that she learned how to tighten the hardware from the provider who was originally coming out to service the chair.In regard to adjusting the wheel locks, the user manual includes a safety inspection checklist which advises to inspect/adjust the wheel locks weekly to ensure that they prevent the wheelchair from moving when engaged.Also, the wheel locks must be periodically adjusted in correlation to tire wear.If the wheel locks do not hold the occupied wheelchair in place, the manual states to contact a qualified technician.Invacare contacted the end user's provider to setup a return/replacement of the wheel locks.The provider advised that she was unaware of the alleged incident and injury.She stated that she did not have any recent notes from the end user.The provider had previously reported a similar wheel lock issue with the chair in (b)(6) 2017.It was alleged that both wheel locks were becoming loose, and the end user had called them at least 10 times to have them tightened.However, when the provider's technician inspected the wheel locks, there were no signs of stripped hardware.Even though there was no evidence of a malfunction, the wheel locks were replaced at that time.These replacement wheel locks have now exceeded their expected wear period of 1 year.At this time, a device malfunction has not been confirmed.Based on available information, the most likely cause of the alleged incident is use error.Rather than raising the armrests and shifting her body weight during transfer, per the user manual instructions, the user placed all of her weight on the armrests, causing the chair to tip over.It is undetermined whether the wheel locks were a contributing factor.An rma (return material authorization) was issued for the wheel locks to be returned to invacare for evaluation.Once they are received and evaluated, a supplemental record will be filed.
 
Event Description
The end user reported that the trsx56fbp wheelchair's wheels locks are loose and are not stopping the wheels from rolling.She also alleged that she was in her bathroom, trying to transfer from the chair to the toilet, when the chair rolled and tipped over and she fell, fracturing her femur in three places.She stated that at the time she didn't realize that the femur was fractured.She was later examined at the hospital, and that is where it was discovered.She stated that she did not receive a cast, because it was not a full break.
 
Event Description
The end user reported that the trsx56fbp wheelchair's wheels locks are loose and are not stopping the wheels from rolling.She also alleged that she was in her bathroom, trying to transfer from the chair to the toilet, when the chair rolled and tipped over and she fell, fracturing her femur in three places.She stated that at the time she didn't realize that the femur was fractured.She was later examined at the hospital, and that is where it was discovered.She stated that she did not receive a cast, because it was not a full break.
 
Manufacturer Narrative
The trsx56fbp wheelchair's wheel locks were returned to invacare, and they received an expanded evaluation, which was completed on 06/10/2019.Through visual inspection of the returned wheel locks, it was determined that the one of the two wheel locks was loose at the lever joint.Based on the presence of the gap between the bolt head and lever, it appeared that the nylon washer had worn such that it fell from the assembly.Based on the age of the chair and condition of the wheel locks, service and/or replacement of the wheel locks was needed.The end user had claimed that she noticed that the wheel locks were loose prior to the alleged event.The invacare tracer sx5 wheelchair owner's manual states, ¿warning: if wheel locks do not hold the occupied wheelchair in place, contact a qualified technician; otherwise injury or damage may occur.¿.
 
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Brand Name
INVACARE TRACER SX5 WHEELCHAIR, FLIP-BACK DESK-LENGTH ARMS 16"X16"
Type of Device
WHEELCHAIR, MECHANICAL
Manufacturer (Section D)
JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD
no.36 danyan road
danyang city, jiangsu
MDR Report Key8581958
MDR Text Key144116104
Report Number1531186-2019-00003
Device Sequence Number1
Product Code IOR
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 06/18/2019,04/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberTRSX56FBP
Device Catalogue NumberTRSX56FBP
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/18/2019
Distributor Facility Aware Date04/08/2019
Device Age3 YR
Event Location Home
Date Report to Manufacturer06/18/2019
Date Manufacturer Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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