MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for POWERED WHEELCHAIR SYSTEM INVA/MATRX MX1 BACK FITS W: 15", H: 12" IMX11512-CR manufactured by Motion Concepts Lp.
[72806518]
This is the first known incident reported of our invacare-matrx mx1 back becoming disengaged from the wheelchair due to the latch hardware not engaging properly, and thereby causing the end user to fall backward from the wheelchair. The mx1 back has been on the market since 2011. At present, motion concepts is not able to complete a thorough investigation, due to a lack of information provided from the dealer. Motion concepts has requested, but to date has not been provided any images of the alleged defective hardware and/or any images to show how the mx1 back was installed on the wheelchair. The alleged defective hardware components are being returned by numotion to motion concepts for our inspection/evaluation, but have not been received at this time. Motion concepts' investigation remains open, pending receipt of additional information.
Patient Sequence No: 1, Text Type: N, H10
[72806519]
On 13-march 2017, motion concepts was notified by numotion (dealer) of an alleged incident involving one of our invacare-matrx mx1 backs. Numotion was informed by the end user that her mx1 back had become disengaged suddenly from her wheelchair causing her to fall backward and bump her head. The end user did not seek medical attention. The dealer alleges the latch mechanism on the hardware was not engaging properly causing the back to become disengage. The original invacare matrx mx1 back (model: imx11512-cr) was sold to numotion in june 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615350-2017-00002 |
| MDR Report Key | 6487418 |
| Date Received | 2017-04-12 |
| Date of Report | 2017-04-12 |
| Device Manufacturer Date | 2016-06-20 |
| Date Added to Maude | 2017-04-12 |
| 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 |
| Reporter Occupation | OCCUPATIONAL THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS DONA BHAMRA |
| Manufacturer Street | 84 CITATION DRIVE UNITS 1-7 |
| Manufacturer City | CONCORD, ONTARIO L4K3C1 |
| Manufacturer Country | CA |
| Manufacturer Postal | L4K3C1 |
| Manufacturer Phone | 6950134 |
| Manufacturer G1 | MOTION CONCEPTS LP |
| Manufacturer Street | 84 CITATION DRIVE UNITS 1-7 |
| Manufacturer City | CONCORD, ONTARIO L4K3C1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | L4K3C1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | POWERED WHEELCHAIR SYSTEM |
| Generic Name | WHEELCHAIR |
| Product Code | KNN |
| Date Received | 2017-04-12 |
| Model Number | INVA/MATRX MX1 BACK FITS W: 15", H: 12" |
| Catalog Number | IMX11512-CR |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MOTION CONCEPTS LP |
| Manufacturer Address | 84 CITATION DRIVE UNITS 1-7 CONCORD, ONTARIO L4K3C1 CA L4K3C1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-04-12 |