MAUDE Adverse Event Report: DRIVE; WHEELCHAIR

Model Number	ATC19BL
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Drive devilbiss healthcare was notified of an incident involving a rollator by an attorney, who reported that "the end user was seated in a transport chair when it collapsed due to a weld break causing him to fall and fracture his left scapula." 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
• MDR Report Key: 15455272
• Report Number: 2438477-2022-00072
• Device Sequence Number: 6881395
• Product Code: IOR
• UDI-Device Identifier: 00822383133621
• UDI-Public: 00822383133621
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/20/2022
• Report Date (Section F): 09/20/2022

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: ATC19BL
• Was the Report Sent to FDA?: Yes
• Event Location: Other
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 09/20/2022