MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT DRIVE DEVILBISS HEALTHCARE CRUISER III TRANSPORT/WHEELCHAIR; WHEELCHAIR, MECHANICAL

Model Number	K318DDA-SF
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified by a healthcare facility of an incident involving a wheelchair.The facility reported that the back upholstery of the wheelchair ripped during use, causing the end user to fall from the chair.As a result of the fall, the end user was transported to a hospital where a ct scan confirmed a concussion.As part of its complaint review and evaluation process, drive devilbiss healthcare will also notify the manufacturer of the product about this complaint.

• Brand Name: DRIVE DEVILBISS HEALTHCARE CRUISER III TRANSPORT/WHEELCHAIR
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT; no. 36 danyan road; danyan city, jiangsu 21230 0; CH 212300
• MDR Report Key: 22577785
• Report Number: 2438477-2025-00033
• Device Sequence Number: 9647308
• Product Code: IOR
• UDI-Device Identifier: 00822383123356
• UDI-Public: (01)00822383123356
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2025
• Report Date (Section F): 07/23/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: K318DDA-SF
• Device Catalogue Number: K318DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2025
• Event Location: Home
• Date Report to Manufacturer: 07/23/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/23/2025