MAUDE Adverse Event Report: MAGIC MOBILITY MAGIC MOBILITY; FRONTIER

Model Number FRONTIER

Device Problem Unstable (1667)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

During our investigation of the frontier s/n (b)(4) it was determined that the loose wheel bolts was due to human error during the assembly process.To this date (6/21/19), this is the only reported occurence of this kind.The quality inspection process has been revised (effective 5/24/19) to inspect every wheel assembly prior to shipping.

Event Description

The dealer fitted the client for the power wheelchair.When client then started to drive a short distance in their home on a tiled surface, it was discovered that the wheel had a wobble; the client was transferred out of the chair.A nut was found on the ground and the dealer began an investigation.It was discovered that the bolts in the left wheel were not tightened.

• Brand Name: MAGIC MOBILITY
• Type of Device: FRONTIER
• Manufacturer (Section D): MAGIC MOBILITY; 2/112 browns road; noble park, vic 3174 ; AS 3174
• Manufacturer Contact: monika gluszak ; 2/112 browns road; noble park, vic 3174 ; AS 3174
• MDR Report Key: 8816557
• MDR Text Key: 152041211
• Report Number: 3002905561-2019-00001
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FRONTIER
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2019
• Distributor Facility Aware Date: 04/26/2019
• Device Age: 3 WK
• Event Location: Home
• Date Report to Manufacturer: 05/23/2019
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Weight: 163