MAUDE Adverse Event Report: DRIVE DEVILBISS HEALTHCARE DRIVE; WALKER, MECHANICAL

Model Number	10210-4ASM
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/22/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Patients experiencing difficulties opening and closing legs of walkers.

• Brand Name: DRIVE
• Common Device Name: WALKER, MECHANICAL
• Manufacturer (Section D): DRIVE DEVILBISS HEALTHCARE; 100 n barranca ave, suite 460; covina CA 91723
• MDR Report Key: 9481058
• Report Number: 9481058
• Device Sequence Number: 16201825
• Product Code: ITJ
• UDI-Device Identifier: 50822383226205
• UDI-Public: (01)50822383226205
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/25/2019
• Report Date (Section F): 11/25/2019

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: Health Professional
• Device Model Number: 10210-4ASM
• Device Lot Number: 5B211511
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/25/2019