MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-06 for INVACARE TRACER SX5 WHEELCHAIR, FLIP-BACK DESK-LENGTH ARMS 16"X16" TRSX56FBP manufactured by Jiangsu Jumao Medical Equipment Co Ltd.
[144116104]
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.
Patient Sequence No: 1, Text Type: N, H10
[144116105]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2019-00003 |
| MDR Report Key | 8581958 |
| Date Received | 2019-05-06 |
| Date of Report | 2019-04-08 |
| Date Facility Aware | 2019-04-08 |
| Report Date | 2019-06-18 |
| Date Reported to FDA | 2019-06-18 |
| Date Reported to Mfgr | 2019-06-18 |
| Date Mfgr Received | 2019-04-08 |
| Device Manufacturer Date | 2016-03-01 |
| Date Added to Maude | 2019-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE TRACER SX5 WHEELCHAIR, FLIP-BACK DESK-LENGTH ARMS 16"X16" |
| Generic Name | WHEELCHAIR, MECHANICAL |
| Product Code | IOR |
| Date Received | 2019-05-06 |
| Model Number | TRSX56FBP |
| Catalog Number | TRSX56FBP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU JUMAO MEDICAL EQUIPMENT CO LTD |
| Manufacturer Address | NO.36 DANYAN ROAD DANYANG CITY, JIANGSU US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-06 |