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

Model Number	EIPW22
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
There were no allegations of malfunction or defect made against the subject wheelchair.The injuries reported were due to the auto incident only.(b)(6), the dealer, requested a quote for repair parts versus a quote for the entire chair for insurance purposes.Sunrise medical's technical support department advised (b)(6) that while a quote for the parts will be provided, an order for the parts will not be processed since the damage to the chair was too extensive and cannot be repaired.Joseph is aware the chair is beyond repair and understood.This mdr filing is to report the incident and the injuries sustained by the end user only.Again, the injuries sustained were due to the accident and not due to a malfunction or deficiency in the subject wheelchair.No further investigation will be performed by sunrise medical at this time.
Event or Problem Description
Per dealer, (b)(6), on (b)(6) 2019 the end user was out getting her mail when a car hit her while she was in her wheel chair.(b)(6) stated the chair is a total loss and the only surviving parts on this chair are a caster and the joystick.Everything else is damaged.The dealer states the end user suffered two fractured hips, 7 pins put in her left shoulder and will require continuous treatments.

• 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: 8480535
• Report Number: 2937137-2019-00011
• Device Sequence Number: 11130527
• Product Code: ITI
• UDI-Device Identifier: 05022408051977
• UDI-Public: 05022408051977
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/11/2019

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: EIPW22
• Device Catalogue Number: EIPW22
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 04/03/2019
• 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; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 68