FDA Adverse Event Injury Summary report: N

SMART DRIVE MX2+

MDR report key: 21067519 · Received January 3, 2025

Report

Report Number
MW5164231
Event Type
Injury
Date Received
January 3, 2025
Date of Event
December 28, 2024
Report Date
January 1, 2025
Manufacturer
MAX MOBILITY- PERMOBIL / MAX MOBILITY, LLC.
Product Code
ITI
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

SMART DRIVE MX2+ WHEELCHAIR POWER ASSIST DEVICE. PERMOBIL THE DEVICE HAS BEEN UPDATED AND MAINTAINED ACCORDING TO THE MANUFACTURER SPECIFICATIONS. THE DEVICE HAS A DEFECT OR DESIGN FLAW THAT CAUSES THE CONTROL TO FAIL TO STOP AND CONTINUE TO ACCELERATE TO MAXIMUM SPEED OF 5.5 MPH WHILE THE OCCUPANT OF THE WHEELCHAIR IS HELPLESS TO STOP IT. THIS DEVICE FAILED AND SENT ME INTO A YOUNG CHILD RUNNING THEM OVER AND THEN INTO A STORE SHELF WHERE THE DEVICE THEN FLIPPED UNDER THE WHEELCHAIR STILL RUNNING CAUSING ME TO BE DANGLING FACING THE FLOOR. I RECEIVED BRUISES AND THE CHILD HAD SCRATCHES AND BRUISES FROM THE FOOTPLATE OF MY WHEELCHAIR. THEY WERE LUCKILY NOT SERIOUSLY INJURED. THE ONLY EMERGENCY WAY TO STOP THE DEVICE IS TO TURN IT COMPLETELY OFF, HOWEVER THE SWITCH ON THE DEVICE IS NOT ACCESSIBLE TO THE WHEELCHAIR USER AS IT IS ON THE BACK AND NEAR THE FLOOR WHEN THE OCCUPANT IS USING THE DEVICE. THE ONLY WAY TO STOP IT WAS HAVING BYSTANDERS IN THIS CASE MY HUSBAND TO MANUALLY TURN IT OFF. THE MANUFACTURER HAS KNOWN ABOUT THIS DESIGN DEFECT SINCE 11/21/2024 HOWEVER I WAS NOT NOTIFIED. THIS DEVICE CAN AND DEFINITELY HAS THE POTENTIAL TO CAUSE SEVERE INJURIES, PROPERTY DAMAGE AND POTENTIALLY FATAL INJURIES ESPECIALLY NEAR ROADWAYS OR OTHER TRAFFIC CONDITIONS AS IT IS THE EQUIVALENT OF A CAR WITH NO BRAKES WHEN IT MALFUNCTIONS. I DO NOT KNOW HOW MANY PEOPLE ARE AFFECTED BY THIS, HOWEVER THE DEVICE NEEDS A REVIEW AND RECALL SO NO ONE ELSE WILL BE SERIOUSLY INJURED OR WORSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
638990 SMART DRIVE MX2+ WHEELCHAIR, POWERED ITI MAX MOBILITY- PERMOBIL / MAX MOBILITY, LLC. 2024-03-20

Patients

Seq Age Sex Outcome Treatment
1 44 YR Female Required Intervention BACLOFEN| IRON | KNEE ANKLE FOOT ORTHOSES| MAGNESIUM| MELOXOCAM| VITAMIN D3| VITAMIN K2| WHEELCHAIR