MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM715; POWERED WHEELCHAIR

Model Number	EIPW11
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical has made several attempts to gather more information about the incident and the end user's condition.(b)(4), the dealer, did not have any details about the incident since it was reported to him by the end user's attorney and was given very limited information.Sunrise medical also attempted to follow up with the dealer to request that he speak with the attorney to retrieve more information.On one occasion (b)(4) did respond and offered to provide sunrise medical with the attorney's contact information.His offer was accepted, however, (b)(4) has not provided the attorney's contact information despite several attempts to reach out to him.Although we have very limited information to come to a proper determination for filing this incident as an adverse event with the fda, out of an abundance of caution, sunrise medical has decided to file this mdr.If and when any new relevant information is provided, a supplemental report will be submitted.No further investigation will be performed by sunrise medical at this time.
Event or Problem Description
On (b)(4) 2018 dealer (b)(4) reported that this chair was involved in a car accident and the end user was thrown from the chair 50 ft.The dealer stated upon receiving additional information about any injuries sustained by the end user he will provide that to sunrise medical.

• Brand Name: QUICKIE QM715
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8022147
• Report Number: 2937137-2018-00014
• Device Sequence Number: 1484294
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/03/2018

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: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 10/30/2018
• 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 Age: 59 YR
• Patient Weight: 145