MAUDE Adverse Event Report: ZHENJIANG ASSURE MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number	RTLREB18DDA-SF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by a caretaker, who stated that he "was pushing man in this wheelchair when the front fork and wheel broke and the chair tipped." the caretaker reported that he was able to catch the end user before the end user hit the floor.There was no report or evidence of illness, injury or medical treatment associated with the complaint.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 EQUIPMENT CO LTD; no.297, chuqiao road; no.39, hengtong road; zhenjiang city, jiangsu 21200 9; CH 212009
• MDR Report Key: 16902498
• Report Number: 2438477-2023-00050
• Device Sequence Number: 5372000
• Product Code: IOR
• UDI-Device Identifier: 00822383270005
• UDI-Public: 00822383270005
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/10/2023
• Report Date (Section F): 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: RTLREB18DDA-SF
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2023
• Device Age: 4 YR
• Date Report to Manufacturer: 05/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/10/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 54 KG
• Date Report Sent to FDA: 05/10/2023