MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE S-646 SE

Model Number	S626/S646
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
Device: s636 (power wheelchair).Sales representative reported that a sunrise medical s636 power wheelchair was involved in a motor vehicle accident (mva).At the time of initial notification, no additional event details were available regarding: whether the wheelchair was occupied.Legal counsel is reportedly involved.
Additional Manufacturer Narrative
Sales reported that a sunrise medical s636 power wheelchair was involved in a motor vehicle accident.No details were available at the time of notification regarding device malfunction, structural failure, or user injury.It is unknown whether the chair was occupied or whether any injury occurred.Legal counsel is reportedly involved.Based on the limited information currently available, there is no evidence that the device caused or whether any injury occurred.Legal counsel is reportedly involved.Conclusion: based on the limited information currently available, there is no evidence that the device caused or contributed to the accident, nor is there confirmation of a reportable malfunction, serious injury, or death under 21 cfr part 803.

• Brand Name: QUICKIE S-646 SE
• Common Device Name: QUICKIE S-646 SE
• 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; mt. juliet TN 37122
• Manufacturer Contact: neeraj patel ; 12002 volunteer blvd; mt. juliet, TN 37122 ; 8003334000
• MDR Report Key: 24483369
• Report Number: 3019677893-2026-00003
• Device Sequence Number: 10676504
• Product Code: ITI
• UDI-Device Identifier: 00016958044256
• UDI-Public: 00016958044256
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/05/2026

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: S626/S646
• Device Catalogue Number: EIS62
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/02/2026
• 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: Unknown