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

Model Number	QUICKIE 700M
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870); Limb Pain (4836)
Date of Event	02/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Per client, on (b)(6) 2025 he was crossing the street to get on the bus and got hit by a car on his right side, he was thrown out of chair on to street, the car stopped since could not go over chair, per client, the chair saved his life, client fractures right side ribs, and hurt his head and teeth since he hit the road when he fell, still getting medical care.The right arm of chair was damaged.
Additional Manufacturer Narrative
Background information: quickie q700m owner's manual, page 7 states: "warning! do not use any wheelchair that has been involved in a motor vehicle accident.A sudden stop and/or collision may structurally damage your wheelchair.There may have been a change to the structure of the chair, and/or damaged or broken some of the components.Wheelchairs involved in sudden stops should be inspected for possible failures in frame and/or components.Frame damage may be represented by but not limited to: visual cracks, dents, metal distortion, bends, or damage to the seating mounting.If the chair no longer drives straight, it could be damaged.If the wheelchair has been involved in an accident, discontinue use immediately and contact your sunrise medical authorized dealer for a thorough inspection.If damage is questionable or if there is concern regarding the condition of the chair, sunrise medical recommends replacement of the chair.Wheelchairs involved in collisions should be replaced.Discussion: in reviewing the complaint, the end user stated the end user was crossing the road and a car hit him.End user says the wheelchair saved his life.The end user claims to have had broken ribs, his head and teeth were impacted due to this accident.A dhr review for this product was conducted and no abnormalities, deviations or ncmr's related to the claim were identified in the manufacturing process.Conclusion: in conclusion, there is no evidence of malfunction or defect from the wheelchair.Due to the allegation of a serious injury that required medical intervention (broken ribs), this mdr is being filed.

• Brand Name: QUICKIE
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n. business park ave.; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 2842 n. business park ave.; fresno CA 93727
• Manufacturer Contact: tanisha gregory ; 12002 volunteer blvd; mt. juliet, TN 37122 ; 8003334000
• MDR Report Key: 23388207
• Report Number: 2937137-2025-00002
• Device Sequence Number: 10047581
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: (01)00016958059793
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2025

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: QUICKIE 700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 62 KG