MAUDE Adverse Event Report: A & I INDUSTRIES LTD. GUARDIAN WALKER; WALKER, MECHANICAL

Model Number G30757W

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 09/03/2020

Event Type  malfunction  

Event Description

Attempted to issue a new, stocked rolling walker to a patient.Adjusted walker and tested for use.Identified faulty wheel prior to issuing.Removed from service.

• Brand Name: GUARDIAN WALKER
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): A & I INDUSTRIES LTD.; 33 golden eagle lane; littleton CO 80127
• MDR Report Key: 10612692
• MDR Text Key: 209391927
• Report Number: 10612692
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G30757W
• Device Lot Number: 18720030001
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/08/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1