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

Model Number	EIPW22
Health Effect - Clinical Codes	Bruise/Contusion (1754); Fall (1848); Fracture, Arm (2351)
Date of Event	11/02/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As stated in the complaint, the injury sustained by the end user may have been due to the accidental fall off of the ramp on his porch.The items being replaced on the wheelchair are for damages sustained from the accidental fall.This mdr filing is to report the broken arm.There were no allegations of malfunction or defect made against the subject wheelchair and the only parts being replaced are the ones affected by the fall.The dealer did not obtain any of the client's vitals such as height, weight or age for this report.Sunrise medical does deem this incident as accidental and there will be no further investigation performed by sunrise medical at this time.
Event or Problem Description
Dealer (b)(6), stated that the client rolled off the porch and he doesn't remember how that happened.Dealer is thinking he made the turn too wide off the ramp he has on his porch.Client broke his arm.Chair landed on the right side damaging the swing away receiver.(b)(6) also stated that he wasn't too sure if the end user was in the hospital for too long.He stated that the end user's face was "black and blue".

• 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: 8122655
• Report Number: 2937137-2018-00016
• Device Sequence Number: 1913210
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/02/2018

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: EIPW22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2018
• Initial Report FDA Received Date: 12/01/2018
• 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