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

Model Number EIPW11

Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 04/07/2019

Event Type  Injury  

Manufacturer Narrative

Per (b)(6), the casters and drive wheels had been replaced before the incident occurred.As of 05/07/2019, the chair has been disposed of due to the age of the chair and a new chair has been ordered.He was unaware of any injuries to the end user.Sunrise medical regulatory performed a history search of this wheelchair and found that throughout the life of this chair, several parts had been replaced.This chair was 6 years old and normal maintenance would be required due to the wear and tear from the chairs use and not due to a malfunction or defect.There were no allegations of malfunction, defect or adverse event when these items were previously requested.It is stated in the wheelchair's owner's manual on page 9, section p.Obstacles: "riding over curbs or obstacles can cause tipping and serious bodily harm.If you have any doubt that you can safely cross any curb or obstacle, always ask for help.Be aware of your riding skills and personal limitations.Develop new skills only with the help of a companion." since the wheelchair was disposed of, per the dealer, sunrise medical is unable to perform an evaluation and confirm the alleged failure mode.There will be no further investigation performed by sunrise medical at this time.

Event Description

End user reported on (b)(6) 2019 to sunrise medical that on (b)(6) 2019, while using the sidewalk ramp, the right drive tire "grabbed" and the left drive tire spun causing the chair to swerve to the left and tip over.End user stated to have received broken ribs.He is being treated for his injuries at the (b)(6).The end user claims that the issue of the right drive tire gripping and the left drive tire spinning has been going on for a few weeks and occurs when he goes up the ramp at home or getting on the bus.

• Brand Name: QUICKIE QM710
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727
• MDR Report Key: 8621460
• MDR Text Key: 145495552
• Report Number: 2937137-2019-00014
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: EIPW11
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/23/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2013
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 125