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

Model Number	EIPW11
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	12/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical attempted to contact (b)(4) a few times via phone calls and email to gather additional information regarding the accident and injuries.(b)(4) returned sunrise medical's customer service calls and email on 2/7/19 and reported the following: "6 weeks ago the user was drinking and was going across the street to get more alcohol and crossed on a red light and was hit by an automobile.The police report stated the automobile driver was at no fault.The user broke a leg, arm, rib and hip.This occurred at night.User is approx.5'10 and weighs approx.(b)(6)." this mdr is being filed to report the injuries sustained while the end user was in our wheelchair; however, this incident is deemed as accidental by sunrise medical.There was no allegation of malfunction or defect made against the subject wheelchair.No further investigation will be performed by sunrise medical at this time.
Event or Problem Description
Dealer, (b)(4), reported to sunrise medical's customer service that the end user was struck by an automobile while in his wheelchair.(b)(4) stated the chair was totaled and the end user broke his hip and leg.

• Brand Name: QUICKIE QM710
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8337939
• Report Number: 2937137-2019-00005
• Device Sequence Number: 206314
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K083249
• 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): 01/30/2019

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: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Weight: 111