MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL DRIVE; WHEELCHAIR

Model Number	K320DDA-SF
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare is an initial importer of the device which is a wheelchair.We have not received the product back for evaluation.The seatbelt on the wheelchair did not lock properly and the end user fell out.She fractured shoulder and surgery was required.
Event or Problem Description
Drive devilbiss healthcare is an initial importer of the device which is a wheelchair.We have not received the product back for evaluation.The seat belt is unknown, not an accessory of the device.The seatbelt on the wheelchair did not lock properly and the end user fell out.She fractured shoulder and surgery was required.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL; 297 chuqiao rd; zhenjiang city, jiangsu 21200 0; CH 212000
• MDR Report Key: 10418303
• Report Number: 2438477-2020-00040
• Device Sequence Number: 11730611
• Product Code: IOR
• UDI-Device Identifier: 00822383123370
• UDI-Public: 822383123370
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/17/2020
• Report Date (Section F): 08/17/2020

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: K320DDA-SF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/20/2020
• Device Age: 9 MO
• Date Report to Manufacturer: 08/18/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/17/2020