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

Model Number DFL19-BL

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); Head Injury (1879); Concussion (2192)

Event Date 06/24/2023

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a transport chair by an end user, who stated that as she attempted to sit in the chair, she "was holding onto the arm rests [and].When she sat down the chair tipped over backwards and hit the back of her head on the pavement." the end user reported that she sustained a concussion and sought medical treatment, including medication for headaches and nausea.The end user confirmed that there was no defect detected with her unit.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
• Type of Device: 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: 17399024
• MDR Text Key: 319802622
• Report Number: 2438477-2023-00105
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383137377
• UDI-Public: 822383137377
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2023,06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DFL19-BL
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/26/2023
• Distributor Facility Aware Date: 06/27/2023
• Event Location: Other
• Date Report to Manufacturer: 07/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 91 KG