MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL DRIVE DEVILBISS HEALTHCARE; WHEELCHAIR, MECHANICAL

Model Number	K318DFA-ELR
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss was notified of an incident involving a wheelchair by the end user who stated that she was attempting to transfer from the bed to the wheelchair using a transfer board when the wheelchair moved causing her to fall to the floor.The end user claims that the brakes were engaged at the time of the event and claims there is an" issue with the brakes." the end user sustained bruising to her right hip and legs and both feet and ankles were swollen.The end user was hospitalized and is now in a rehabilitation facility.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
• Common Device Name: WHEELCHAIR, MECHANICAL
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL; no.36, danyan road; yanling town; danyang, jiangsu 21230 0; CH 212300
• MDR Report Key: 19991286
• Report Number: 2438477-2024-00041
• Device Sequence Number: 7075956
• Product Code: IOR
• UDI-Device Identifier: 00822383133881
• UDI-Public: 00822383133881
• Combination Product (Y/N): N
• 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): 08/15/2024
• Report Date (Section F): 08/15/2024

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: K318DFA-ELR
• Device Catalogue Number: K318DFA-ELR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/26/2024
• Event Location: Home
• Date Report to Manufacturer: 08/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2024
• 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: Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/15/2024