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

Model Number	EIPW22
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The dealer requested a replacement set of footplates, which were shipped on 1/8/2019, stating the current footplates are no longer staying in the up position.The dealer was provided an rma to return the footplates for evaluation for warranty processing.The footplates falling from the up position to the down position, if were to recur, is not likely to cause or contribute to a death or serious injury.Although the footplates did not directly cause or contribute to the injury and the injury was not serious, as no medical attention was performed or required, sunrise medical has decided to file this mdr out of an abundance of caution.No further investigation will be performed by sunrise medical at this time.
Event or Problem Description
End user was trying to get her mail, the footplates were in the up position so she could reach for her mail.The footplates came down and hit the back of her heels which caused a small scratch on the back of the heel.In that moment she grabbed the joystick, in order to hold on to something.She had the chair on at the time and it started moving forward which caused her to run into the wall.She was taken by ambulance to find out she fractured her toe.After being examined, she was advised that she would have to let both the wound and the fractured toe heal by itself.No stitches or any medical treatment were needed.

• Brand Name: QUICKIE PULSE
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 8295031
• Report Number: 2937137-2019-00004
• Device Sequence Number: 11360050
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• 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): 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: EIPW22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 01/31/2019
• 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: 81