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

Model Number EIPW11

Device Problem Material Twisted/Bent (2981)

Patient Problem Bone Fracture(s) (1870)

Event Date 05/07/2019

Event Type  Injury  

Manufacturer Narrative

There was no allegation of malfunction or defect made against the wheelchair.The items that required repair were the left side arm rest and the joystick.Both items were returned to sunrise medical and an evaluation was performed on 5/23/2019.The test performed on the joystick revealed a pm 7f00 fault code.This occurs when the control system detects a fault in the wiring in the communication cables between any of the modules.This fault code would be displayed to the user as an indication that service is required as an issue may need to be addressed.Depending on the severity of connection issue, the chair may still allow the user to use the wheelchair to drive and perform seating functions while this fault is being displayed.For more severe connection faults where a cable may be damaged preventing communication from passing through, the fault could prevent the chair from being operated until the issue has been identified and resolved.It is possible that the joystick was damaged during the fall, causing the 7f00 fault that is now occurring, however this fault would not have caused the chair to drive without joystick input.No further investigation will be performed by sunrise medical at this time.

Event Description

Dealer states an attendant at the (b)(6) foundation was unloading the end user from a transport van and the end user drove right off the loading platform.The lady at the facility thinks the barrier was up and that the end user drove right over it.The end user and the chair landed on its left side.The left side arm rest got bent.The end user broke her left arm.

• 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 ; 5592942840
• MDR Report Key: 8675785
• MDR Text Key: 147238058
• Report Number: 2937137-2019-00015
• 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: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2019
• 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: 05/22/2019
• Date Manufacturer Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 61