MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS CORP. QUANTUM Q6 EDGE POWER CHAIR; WHEELCHAIR, POWERED

Model Number Q6 EDGE 3 3MP-SS

Device Problems Mechanical Problem (1384); Product Quality Problem (1506); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2020

Event Type  Injury  

Event Description

The quantum q6 edge power chair is my main method of movement within my home.On (b)(6) 2020 while in the recline position, as is required for my health regimen, an error message appeared on the control mechanism.This resulted in the chair, while i was reclined back to lock in that position and there is no mechanism to bring the chair manually to the upright sitting position.In order to get out of the chair, the (b)(6) fire department had to respond and lift me out of the chair, into my back up manual wheelchair.We contacted the vendor which we purchased it from, (b)(6) medical, who came late afternoon on (b)(6) 2020.The chair had a faulty regulator which ruined the battery, which is the reason the chair shut down.The concern is that there is no default on the power chair to allow it to manually be lowered or revert to the sitting position.In conversation with the technician, at (b)(6) medical, he confirmed that quantum does not have this in their chairs, as a result, if a person was unable to call for assistance, it could result in a life threatening situation due to the position of the person in the chair with their head below their feet and inability to be extracted even with another person present from the chair.Since the primary use is by persons unable to ambulate by themselves, with no method to allow the chair to go to the sitting position which is the only way to get out of the chair, is a critical fault in the safety of the chair.No medical tests were required.Fda safety report id# (b)(4).

• Brand Name: QUANTUM Q6 EDGE POWER CHAIR
• Type of Device: WHEELCHAIR, POWERED
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS CORP.
• MDR Report Key: 10520759
• MDR Text Key: 206780010
• Report Number: MW5096538
• Device Sequence Number: 1
• Product Code: ITI
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 3 3MP-SS
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 95