MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE QM720; POWERED WHEELCHAIR

Model Number	EIPW11
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On (b)(6) 2018 i spoke with (b)(4) at (b)(4) inquiring about the accident since it was not clear as to what type of accident it was.(b)(4) confirmed with his colleague (b)(4) that it was an auto accident where a car hit the end user while he was in his chair.(b)(4) did confirm the end user suffered a broken arm and nothing else.There were no allegations of malfunction or defect made against the wheelchair.Attempts were made to obtain the end user's vitals such as height, weight and age; however, the dealer has not responded.An additional email sent to (b)(4) on 11/16/18, in which we are still waiting for her response.An mdr is being filed to report the broken arm sustained by the end user from the automobile accident.It is stated in the fda regulation 21 cfr 803 for medical device reporting, that manufacturers are required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.Although this incident involved a car that struck the end user and the injury was not caused by the subject wheelchair, sunrise medical, out of an abundance of caution, chose to file this mdr.No further investigation will be performed by sunrise medical at this time.
Event or Problem Description
On "(b)(6)" 2018 per dealer (b)(4), the end user involved in an accident while in their power wheelchair.Customer got injured with a broken arm but everything else is ok.Per the dealer, the chair is at the police station and their tech is going to pick it up to look at the damage.

• Brand Name: QUICKIE QM720
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8126211
• Report Number: 2937137-2018-00017
• Device Sequence Number: 11195710
• 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): 11/16/2018

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: 11/14/2018
• Initial Report FDA Received Date: 12/03/2018
• 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; Required Intervention