MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q700-UP M / Q700M

Model Number	Q700-UP M / Q700M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On march 18, 2026, the dealer was informed that an end user on mobility chair was involved in a motor vehicle accident while in use by a male client.The device was determined to be non-repairable and will be disposed of.The client sustained a serious injury, reported as a fractured left hand.A replacement chair has been quoted (ref: (b)(4).Additional patient demographics (age, height, weight) are pending.
Event or Problem Description
On march 18, 2026, the dealer was reported that the end user was on mobility chair and was involved in a motor vehicle accident while the client was operating the chair.The chair was deemed non-repairable and will be disposed of.A replacement chair quote (ref: (b)(4) has been processed.The male client sustained injuries, including a fractured left hand.Additional patient details (age, height, and weight) are pending from the dealer.

• Brand Name: QUICKIE Q700-UP M / Q700M
• Common Device Name: Q700-UP M / Q700M
• Manufacturer (Section D): SUNRISE MEDICAL (US) LLC; 2842 n business park ave; fresno CA 93727
• Manufacturer (Section G): SUNRISE MEDICAL (US) LLC; 12002 volunteer blvd; mount juliet TN 37122
• Manufacturer Contact: david pointer ; 2842 n business park ave; fresno, CA 93727
• MDR Report Key: 24872635
• Report Number: 3019677893-2026-00007
• Device Sequence Number: 9899794
• Product Code: ITI
• UDI-Device Identifier: 00016958059793
• UDI-Public: 00016958059793
• Combination Product (Y/N): N
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2026

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: Q700-UP M / Q700M
• Device Catalogue Number: EIPW25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Other
• Patient Sex: Male