MAUDE Adverse Event Report: JIANGYIN HUASHI MEDICAL EQUIPMENT CO LTD DRIVE; WHEELCHAIR

Model Number	795BU
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Drive devilbiss healthcare was notified of a complaint regarding a rollator/transport chair by a provider, who stated "it will lock when trying to push it," which reportedly caused the end user to fall, but "her caregiver grabbed her." 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): JIANGYIN HUASHI MEDICAL EQUIPMENT CO LTD; no. 589 hualu road,; no.39, hengtong road; huashi town, jiangsu 21442 1; CH 214421
• MDR Report Key: 16995018
• Report Number: 2438477-2023-00053
• Device Sequence Number: 15220590
• Product Code: ITJ
• UDI-Device Identifier: 00822383221649
• UDI-Public: 00822383221649
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/24/2023
• Report Date (Section F): 05/24/2023

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: 795BU
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/24/2023
• Device Age: 10 MO
• Date Report to Manufacturer: 05/31/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 05/24/2023