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

Model Number CX420ADDA-SF

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Type  Injury  

Event Description

Drive devilbiss healthcare was notified of an incident involving a wheelchair by provider who stated that "the wheel broke off and the end user fell in the unit," and was reportedly taken to the hospital by ambulance where he was admitted.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: 16364039
• MDR Text Key: 309407196
• Report Number: 2438477-2023-00009
• Device Sequence Number: 1
• Product Code: IOR
• UDI-Device Identifier: 00822383528366
• UDI-Public: 00822383528366
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: CX420ADDA-SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2023
• Distributor Facility Aware Date: 01/20/2023
• Device Age: 11 MO
• Date Report to Manufacturer: 02/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 120 KG