MAUDE Adverse Event Report: UNKNOWN WALKER PLATFORM ATTACHMENT 9153632821; WALKER, MECHANICAL

Model Number 1030KW

Device Problem Fitting Problem (2183)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Dealer states there is a welded nut on the adjustment piece on the tiller that allows the handlebars to move up and down.The screw is not able to fit into the nut.Out of box failure.Original order (b)(4).

• Brand Name: WALKER PLATFORM ATTACHMENT 9153632821
• Type of Device: WALKER, MECHANICAL
• Manufacturer (Section D): UNKNOWN; OH
• Manufacturer (Section G): UNKNOWN; OH
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4375847
• MDR Text Key: 5238896
• Report Number: 1525712-2014-09041
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: GA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/09/2014

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
• Device Operator: Lay User/Patient
• Device Model Number: 1030KW
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other