MAUDE Adverse Event Report: JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD DRIVE; WHEELCHAIR

Model Number	SSP218DFA-SF
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Bone Fracture(s) (1870)
Date of Event	10/20/2019
Type of Reportable Event	Death
Event or Problem Description
Drive devilbiss healthcare is the initial importer of the device which is a wheelchair.The end-user's family is in possession of the wheelchair.It is not available for evaluation.The end-user's family member has advised that the end-user was being transported by a local transport company.The brakes of the chair were not locked.The wheelchair rolled down the ramp.The end-user fell and broke his femur.He reportedly died from the fall.The transport company is suggesting that the device was faulty.Date of death and medical information is not available due to hippa restrictions.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD; no.36 danyan road; danyang jiangsu,; 21230 0; CH 212300
• MDR Report Key: 9629000
• Report Number: 2438477-2020-00005
• Device Sequence Number: 11491299
• Product Code: IOR
• UDI-Device Identifier: 00822383268873
• UDI-Public: 822383268873
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2020
• Report Date (Section F): 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Model Number: SSP218DFA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2020
• Device Age: 4 MO
• Event Location: Other
• Date Report to Manufacturer: 01/27/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2020
• 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: Death; Hospitalization
• Date Report Sent to FDA: 01/24/2020