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

Model Number	EIPW22
Health Effect - Clinical Codes	Crushing Injury (1797); Bone Fracture(s) (1870); No Code Available (3191)
Date of Event	09/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After clarifying the "crushed" reference in the original complaint as recorded by sunrise medical's customer service representative, the reference was being made to describe the damage to several parts of the subject wheelchair.A letter stating sunrise medical's recommendation to replace the wheelchair was provided to the dealer to submit to the end user's insurance agency in order to request a replacement chair.The end user is currently in a loaner chair.The dealer also confirmed that the injuries sustained by the end user were broken bones to the left hand and a shoulder injury, which have been treated by a medical professional.This mdr filing is to report the injuries sustained due to the auto accident.There were no allegations of malfunction or defect made against the subject wheelchair.No further investigation will be performed by sunrise medical.
Event or Problem Description
On (b)(6) 2018 per dealer, the client was crossing the street at a cross walk and was hit by an oncoming truck.The chair was hit in right rear, chair was crushed.The client received injuries, broken bones in hands, shoulder injury and bilateral prosthetic damage.

• Brand Name: QUICKIE PULSE
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7976346
• Report Number: 2937137-2018-00012
• Device Sequence Number: 1380055
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 10/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 100