MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q500/Q400 SERIES; Q500M-Q400M QUICKIE Q500/Q400 SERIES

Model Number	Q500/Q400
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Type of Reportable Event	Serious Injury
Event or Problem Description
On 02/10/2026, manufacturer was made aware that an client/end user was operating the power wheelchair on a sloped sidewalk when the left caster wheel reportedly turned and cracked.As a result, the wheelchair came to an abrupt stop.The client/end user was wearing a seat belt at the time of the incident and reportedly lunged forward against the restraint when the chair stopped suddenly, resulting in a whiplash-type motion of the neck.The client/end user is currently reporting neck pain.At the time of the report, it was unknown whether the client/end user sought or received medical evaluation or treatment.
Additional Manufacturer Narrative
Based on the information currently available, the incident involved an abrupt stop of the power wheelchair following an alleged cracking of the left caster wheel, with the client/end user subsequently reporting neck pain consistent with a whiplash-type motion.At this time, no confirmation of medical evaluation or treatment has been received, and the device has not yet been evaluated.Conclusion.Since the end user had neck injury, this mdr has been filed.

• Brand Name: QUICKIE Q500/Q400 SERIES
• Common Device Name: Q500M-Q400M QUICKIE Q500/Q400 SERIES
• 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: 24496414
• Report Number: 3019677893-2026-00004
• Device Sequence Number: 4979763
• Product Code: ITI
• UDI-Device Identifier: 00016958059823
• UDI-Public: 00016958059823
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/10/2026

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: Q500/Q400
• Device Catalogue Number: EIPW30
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Initial Report FDA Received Date: 03/03/2026
• 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
• Patient Weight: 86 KG