MAUDE Adverse Event Report: MAGIC MAGIC MOBILITY; FRONTIER

Model Number FRONTIER V6

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Smoke and sparks from wheelchair armrest.

• Brand Name: MAGIC MOBILITY
• Type of Device: FRONTIER
• Manufacturer (Section D): MAGIC; 2/112 browns road; noble park, vic 3174 ; AS 3174
• Manufacturer (Section G): MAGIC MOBILITY; see previous; AS
• Manufacturer Contact: jill barnett ; see previous
• MDR Report Key: 7959025
• MDR Text Key: 125115400
• Report Number: 3003650116-2018-00003
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K030783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FRONTIER V6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 50