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

Model Number	EIPW11
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sunrise medical's account manager, (b)(4) contacted the dealer on 6/12/2019 to follow up on this incident.(b)(4) stated the police report was available and it reported that the woman in the wheelchair was crossing the street at a cross walk when someone in a (b)(6) truck struck her.The police cited the driver for being at fault for the accident.There was no allegation of malfunction or defect made against the wheelchair that may have caused or contributed to the accident.(b)(4) also stated that the woman was injured and is in the hospital; however the injuries sustained and the treatment received for the injuries are unknown.Sunrise medical considers this incident as accidental and no further investigation will be performed.
Event or Problem Description
On 6/5/2019 a (b)(4) dealer called in stating that on (b)(6) 2019 a power wheelchair was hit by a car while the end user was in the wheelchair.The dealer states the end user was injured and sought medical attention.However, there was no other information available regarding the end user's condition and the incident that the dealer could provide at that time.

• 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: 8710038
• Report Number: 2937137-2019-00019
• Device Sequence Number: 2662911
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/05/2019

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
• Device Catalogue Number: EIPW11
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2019
• Initial Report FDA Received Date: 06/18/2019
• 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: 73