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

Model Number	ATC19-BL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Fall (1848)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a wheelchair by an end user, who stated that "the back of it broke off right straight across both sides," causing her to fall backwards and land on the floor.She reported sustaining some bruises on her hips, and that "her whole body was stressed." she used her life alert device to obtain medical attention, and was in the hospital for 6 days, however, did not sustain any injuries besides the bruising.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.
Additional Manufacturer Narrative
Drive devilbiss healthcare previously reported the incorrect manufacturer name in section d3 and f14.The information has been updated in these sections to reflect the correct manufacturer name.

• 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: 15553399
• Report Number: 2438477-2022-00098
• Device Sequence Number: 12307017
• Product Code: IOR
• UDI-Device Identifier: 00822383133621
• UDI-Public: 00822383133621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023
• Report Date (Section F): 12/12/2023

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
• Device Model Number: ATC19-BL
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/08/2022
• Device Age: 6 YR
• Event Location: Home
• Date Report to Manufacturer: 12/12/2023
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 12/12/2023