MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM710; POWERED WHEELCHAIR

Model Number EIPW11

Device Problems Loose or Intermittent Connection (1371); Device Fell (4014)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/09/2019

Event Type  Injury  

Manufacturer Narrative

In reviewing the history of this wheelchair, sunrise medical regulatory has found that a replacement order for the joystick mount and joystick cable was placed on (b)(6) 2018 and a 2nd order was placed on (b)(6) 2019.However there were no complaints or allegations of malfunction or defect made against these items at the time that these two orders were placed.In this recent incident a quote for replacing the same joystick mount was provided to the dealer on 5/8/19.The quote was set up as a warranty issue, however, as of today 6/7/19, the item has not been ordered.In further investigating this incident, sunrise medical regulatory has come to a reasonable conclusion that these items were likely replaced due to misuse.The reporting dealer has not provided any additional information since the initial complaint was called in, nor has he returned the items for an evaluation as was requested of him.If and when any additional relevant information if provided or part(s) are returned for evaluation, a supplemental report will be filed with our findings.

Event Description

Per the dealer, (b)(4), the retractable joystick came loose and caused the joystick to fall.Per (b)(4), when the end user was navigating the chair in their home, the joystick fell causing the chair to keep driving without stopping and then the end user ran into a dog cage which they broke their legs and was hospitalized for the injuries.

Manufacturer Narrative

Product was received by sunrise medical and an evaluation was performed and completed by a sunrise medical quality engineer and r&d engineer.The findings are as follows: the part was evaluated by quality engineering and r&d engineering on 2/26/2020.The part functioned as intended.The swing away joystick arm rotated as intended.The clamp was tightened appropriately to hold the swing away joystick mount.The clamp did not have any noticeable cosmetic damage or stripped threads.The most probable root cause would be under tightening of the clamp.This risk assessment was evaluated in the ufmea.Risk id 12 stating, "user exerts excessive force on joystick" and risk id 84 stating "excessive wear or lack of product functionality" were assigned to this incident report.The product's risk scoring of "9" falls within the acceptable range and a corrective action is not required.However, this issue is being monitored in the ufmea by sunrise medical's quality and r&d engineers.No further investigation will be performed.

Event Description

Please see initial mdr 2937137-2019-00016.

• Brand Name: QUICKIE QM710
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno, ca CA 93727
• MDR Report Key: 8681058
• MDR Text Key: 147447202
• Report Number: 2937137-2019-00016
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (y/n): N
• PMA/PMN Number: K083249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIPW11
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2020
• Date Manufacturer Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 99