MAUDE Adverse Event Report: SUNRISE MEDICAL (US) LLC QUICKIE Q300M

Model Number	Q300M
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device Tipped Over (2589); Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A distributor reported that an end user with a prior history of multiple accidents was involved in a mobility transportation incident in which the wheelchair was not secured.During a vehicle collision (t-bone impact), the end user was ejected from the wheelchair, and the chair subsequently landed on him.The end user was transported to the hospital and sustained rib fractures.The exact date of the incident is unknown.An assessment of the wheelchair is required to determine structural integrity before any repair or replacement actions are taken.
Event or Problem Description
A distributor reported that an end user, who has a history of multiple prior accidents within a six-month period (including injuries leading to wheelchair use), was involved in a recent incident while traveling in a mobility taxi.The wheelchair was not properly secured, and the vehicle was t-boned, resulting in the end user being ejected from the chair, with the chair subsequently landing on him.The end user was taken to the hospital and sustained rib fractures.The exact date of the incident is currently unknown.The distributor indicated intent to request replacement parts; however, evaluation of the wheelchair's structural integrity is pending prior to further action.

• Brand Name: QUICKIE Q300M
• Common Device Name: Q300M
• 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: 24884686
• Report Number: 3019677893-2025-00005
• Device Sequence Number: 18600589
• Product Code: ITI
• UDI-Device Identifier: 00016958060485
• UDI-Public: 00016958060485
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: Q300M
• Device Catalogue Number: EIPW40
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (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