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	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6), the dealer, called to report the incident only.There were no allegations against the subject wheelchair of a malfunction or defect that caused or contributed to the adverse event.There was no request for wheelchair parts since there were no failed items that needed to be replaced.(b)(6) stated the only damage to the wheelchair was cosmetic and requested that sunrise medical document the incident.Sunrise medical is filing this mdr to report the injury only.The present condition of the end user at the time of this filing is unknown.As there were no allegations of deficiency in the subject wheelchair, this incident was deemed by sunrise medical's regulatory and quality team as accidental.There will be no further investigation performed by sunrise medical.
Event or Problem Description
Per the dealer (b)(6) at (b)(6), on (b)(6) the patient was crossing the street with his wheelchair and hit a divot in the road causing the wheelchair to flip over.The patient broke his clavicle and was admitted into icu for fluid around his lungs.

• 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: 7768728
• Report Number: 2937137-2018-00010
• Device Sequence Number: 19455032
• Product Code: ITI
• UDI-Device Identifier: 05022408052363
• UDI-Public: 05022408052363
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/17/2018

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2018
• Initial Report FDA Received Date: 08/09/2018
• 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: Required Intervention
• Patient Age: 45 YR
• Patient Weight: 82