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

Model Number	EIPW11
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Concussion (2192); Joint Dislocation (2374)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per frank's boss, dave, when the chair flipped on its side it flipped onto its right side.Dave advised the end user dislocated and fractured his right shoulder.The concussion was stated to be mild so he is doing okay.Dave states nothing seems to be damaged on the right side from the accident.Dealer says he is unsure what caused the incident.Sunrise regulatory researched the history of this wheelchair and found no issue of this type previously recorded.The mother states in the complaint that her son was driving backwards while talking with this friends.The speed of the chair and the angle in which he drove off the paved area onto the grass is unknown.Warnings concerning obstacles and driving in reverse are stated in the wheelchair owner's manual.Page 9, section p.Obstacles states: riding over curbs or obstacles can cause tipping and serious bodily harm.If you have any doubt that you can safely cross any curb or obstacle, always ask for help.Be aware of your riding skills and personal limitations.Develop new skills with the help of a companion.Claus 2 states: keep your eyes moving when you ride; scan the area well ahead of your chair.Section q.Driving in reverse, states: use extra care when you drive your chair in reverse.You may lose control or fall if one of the rear wheels hits an object.Operate your chair slowly and at an even speed.Stop often and check to make sure your path is clear of obstacles.It is unlikely the wheelchair will be released to sunrise medical for inspection since the mother mentioned the family will possibly seek legal counsel.The dealer was unable to determine what may have caused the incident.He also could not confirm that a malfunction or defect occurred that may have caused or contributed to the incident.Sunrise medical regulatory and quality logically concluded that the incident occurred due to end user misuse and failure to follow instructions as previously listed from the owner's manual.However, if the wheelchair is released for evaluation and inspection, a follow up report may be filed with any new and relevant information.
Event or Problem Description
Dealer frank at national seating & mobility called to report that he received an email from an end user's mother stating, "jordan was driving backward talking to his friends.He drove off the sidewalk & on to the grass with a little dip.The wheelchair flipped over on the side.Jordan was in the wheelchair when it flip over on the side.Jordan has a fractured & dislocated shoulder & a slight concussion from the fall.".

• 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: 9588523
• Report Number: 2937137-2020-00004
• Device Sequence Number: 19734014
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 12/17/2019

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: 12/17/2019
• Initial Report FDA Received Date: 01/14/2020
• 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
• Patient Age: 12 YR
• Patient Weight: 50