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

Model Number EIPW22

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Hip Fracture (2349)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

There were no allegations of malfunction or defect made against the subject wheelchair.The fall was accidental as the end user's jacket sleeve got caught on the joystick causing the chair to move forward.The end user is a veteran and this incident was reported to the (b)(6) so that they may offer any assistance the veteran may require.This mdr is being filed to report the injury only.No further investigation will be performed by sunrise medical.

Event Description

End user states he was at a restaurant, stood to take off his jacket when the sleeve got caught on the joystick causing the chair to lurch and him to fall.States he broke his hip and had surgery on (b)(6) 2018.

• Brand Name: QUICKIE PULSE
• 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: 8236807
• MDR Text Key: 132776414
• Report Number: 2937137-2019-00002
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142457
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIPW22
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/18/2018
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 85