MAUDE Adverse Event Report: INVACARE CORP. MATRX ELITE E2 BACK; ACCESSORIES, WHEELCHAIR

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event Description

One side of the wheelchair back seating assembly made by medbloc inc for a matrx elite e2 back by invacare came apart completely and fell on the floor of my living/dining room.In the event that both sides came apart the back would have completely come off my wheelchair and i would've been seriously injured.Upon inspection by my father who is a mechanically inclined individual, he showed me that one tiny screw was holding the assembly on each side of my wheelchair.He was able to fix it but recommended that a compound such as loctite be used to make sure that the back assembly remains in place.While i'm not an engineer, i fail to see how a tiny screw can secure an entire assembly, seeing as i am a 51-year-old man with cerebral palsy, and the assembly is going to be subject to repeated stress, because i use a wheelchair every day and i am diagnosed as spastic quadriplegic.Furthermore, the wheelchair back is designated as durable medical equipment, and as such as a five year lifespan, however there is no way that such a tiny screw is going to last five years.Finally, if both sides of the assembly failed, it could cause serious or deadly injury such as a fall on the floor headfirst, causing concussion or skull fracture.Recommend that the fda look into ways to secure this screw so that it will not come loose, and stand up to the pressure of daily use repeatedly over a period of five years.

• Brand Name: MATRX ELITE E2 BACK
• Type of Device: ACCESSORIES, WHEELCHAIR
• Manufacturer (Section D): INVACARE CORP.
• MDR Report Key: 19004014
• MDR Text Key: 339102029
• Report Number: MW5153368
• Device Sequence Number: 1
• Product Code: KNO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/26/2024

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Race: White