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

Model Number	EIPW11
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	11/03/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In researching the subject wheelchair, there was no history found of repairs being done to this chair prior to this legal complaint that we, sunrise medical (us) llc, received on june 1, 2018.The wheelchair owner's manual does state on page 9, section m.Transfers, item 6, and first bullet point: "as a standard rule, never stand on footrests when you transfer.Doing so may damage them or cause your chair to tip." at this time it cannot be determined if a malfunction occurred since we did not receive a service call for these part(s) nor were we given the opportunity to inspect the damaged part(s) to determine the root cause of the failure when this incident allegedly occurred back on (b)(6) 2016.Sunrise medical's legal department is investigating and addressing this claim.
Event or Problem Description
A legal complaint notice was received by sunrise medical (us) llc on june 1, 2018 from (b)(6) attorneys at law stating the following allegation: on (b)(6) 2016, at approximately 4:30 pm, our client (plaintiff), was being strapped on his wheelchair when placed his feet on the foot pedals for support, the left pedal broke causing him to fall forward.As a result of this fall my client was injured.Following the fall my client was transported to (b)(6) medical center by ambulance with complaints of leg pain.(b)(6), pa diagnosed him with lower fracture extremity and discharged him with instructions for follow-up care.Plaintiff was placed with long leg splint and discharged him with instructions for follow-up care.

• Brand Name: QUICKIE QM710
• Common Device Name: WHEELCHAIR POWERED
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 business park ave.; fresno CA 93727
• MDR Report Key: 7619807
• Report Number: 2937137-2018-00008
• Device Sequence Number: 1589816
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/01/2018

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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 06/20/2018
• 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
• Patient Age: 12 YR
• Patient Weight: 68