DRIVEMEDICAL STD28ECDDARecalls & reported problems

Drive Devilbiss Healthcare · Transport/WheelchairWheelchairs K6 Product Description: Sentra EC,28"Det.DeskArm,1/cs · Class 1

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00822383137247), received between Jul 20, 2024 and Jul 20, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanical Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Mechanical Problem1

Patient problems

Limb Fracture1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJul 20, 2024Mechanical Problem; Mechanical Problem
DRIVE DEVILBISS WAS NOTIFIED OF AN INCIDENT INVOLVING A WHEELCHAIR BY THE END USER WHO REPORTED THAT THE BRAKES DID NOT LOCK WHEN THE END USER WENT TO SIT DOWN ON THE DEVICE. THE END USER SLID DOWN OFF THE CHAIR AND CAUGHT HER RIGHT LEG UNDER THE CABINET WHICH THEN TWISTED CAUSING HER TO FRACTURE HER FIBULA AND ANKLE. THE END USER HAD A CAST FOR 16 WEEKS. AS PART OF ITS COMPLAINT REVIEW AND EVALUATION PROCESS, DRIVE DEVILBISS HEALTHCARE WILL ALSO NOTIFY THE MANUFACTURER OF THE PRODUCT ABOUT THIS COMPLAINT.
Patient problems: Limb Fracture
MAUDE report 19787012 ↗

Device details

UDI-DI	`00822383137247`
Brand	DRIVEMEDICAL
Model	STD28ECDDA
Company	Drive Devilbiss Healthcare
Product code	IOR · Wheelchair, mechanical
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Oct 3, 2024

Device type (GMDN): Attendant-only-propelled wheelchair, non-bariatric

A non-powered wheeled mobility device with a seat designed to enable a healthcare provider/carer to transport a non-bariatric person without the full capacity to walk, typically over short distances and over smooth ground. Often referred to as a transport wheelchair, it is typically designed with four small wheels and includes rear-fitted handles for attendant control of the chair; it does not provide the occupant a mechanism for self-propulsion (it is not a push-rim wheelchair). It provides no function outside of wheeled mobilization.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.