MAUDE Adverse Event Report: BURKE, INC. PACESAVER PASSPORT JR.; SCOOTER

Device Problems Fire (1245); Inadequate Storage (1600); Environmental Compatibility Problem (2929)

Patient Problem No Code Available (3191)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Received a report of a fire on the back porch of a house.Smoke and fire damage to the house.No one was living at the house at the time of the fire, unoccupied.There were no injuries as a result of the fire.We believe the scooter involved was a model discontinued in 2007.The scooter was exposed to elements and unsecured on deck at back of house.Because of the unique situation we sent an engineer to investigate the fire scene.

Manufacturer Narrative

Investigation of fire scene.Based on frame and components we believe the scooter was a passport jr.This model was built between 2002 and 2007.Engineer was at fire scene when evidence was removed.The unit was badly damaged and the serial number could not be recovered.The scooter was at an unoccupied house.It is alleged the scooter was being charged.Scooter was outside on (b)(6) 2015.The scooter was exposed and unsecured.There is a partial overhang that covered part of the unit.We believe the fire started in the general area of the unit.The deck partial overhang and some areas of the house roof received significant damage from the fire.There was smoke and water damage in the house living area.The age of the unit and presence of later date batteries on the unit not from burke.The charger supplied by burke was not found.A power cord from another mobility charger was found at the house.Source of battery charger used on unit at time of fire is not known.Manual warns against exposing unit to moisture and freezing conditions.Unit is held in a secured area by insurance company.There will be an investigation of the unit at a later date and our engineer will travel to participate.We will follow up if new information becomes available.

• Brand Name: PACESAVER PASSPORT JR.
• Type of Device: SCOOTER
• Manufacturer (Section D): BURKE, INC.; 1800 merriam ln.; kansas city KS 66106
• Manufacturer Contact: duwayne kramer jr. ; 1800 merriam ln.; kansas city, KS 66106 ; 9137225658
• MDR Report Key: 4564823
• MDR Text Key: 5550231
• Report Number: 1919278-2015-00001
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: No
• 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