MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMEN DRIVE; WHEELCHAIR

Model Number	STD22ECDDA
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Fall (1848); Spinal Column Injury (2081)
Date of Event	10/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair chair by an end user's son, who stated that the end user "passed out" out while in the chair and the frame of the chair broke and caused the end user to fall to the floor, sustaining a fracture to his back.Drive is currently investigating the incident, including attempting to retrieve the product and inspect it, and will file an update if additional information becomes available.

• Brand Name: DRIVE
• Common Device Name: WHEELCHAIR
• Manufacturer (Section D): ZHENJIANG ASSURE MEDICAL EQUIPMEN; no.297, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 15915083
• Report Number: 2438477-2022-00116
• Device Sequence Number: 14628224
• Product Code: IOR
• UDI-Device Identifier: 00822383136011
• UDI-Public: 00822383136011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2022
• Report Date (Section F): 12/02/2022

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: STD22ECDDA
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2022
• Device Age: 3 YR
• Date Report to Manufacturer: 12/12/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2022
• 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 Sex: Male
• Patient Weight: 129 KG
• Date Report Sent to FDA: 12/02/2022