MAUDE Adverse Event Report: FREERIDER FREERIDER; LUGGIE STANDARD

Model Number LUG3ANRJBBACA3

Device Problems Thermal Decomposition of Device (1071); Burst Container or Vessel (1074); Fire (1245); Smoking (1585); Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  No Answer Provided  

Manufacturer Narrative

Three major differences in battery box: freerider's battery with a step in front edge.Mrs.(b)(6)'s battery with bevel.Freerider's battery with a embossed logo, mrs.(b)(6)'s battery with a big label.Our original battery pack with horizontal stripes but mrs.(b)(6)'s battery without this feature.

Event Description

On the evening of (b)(6) 2017, mrs.(b)(6)'s husband plugged the charger into the charging socket of the luggie between 11.30pm and midnight.Around 1.45am, mrs.(b)(6) noted the charging fan had stopped and that the charging light was green indicating the batteries were fully charged.She got on the scooter reached forward to unplug the power cable from mains and then went to turn the scooter on to operate it, the on button red light illuminated but when she pushed the wig wag to operate the scooter, it wouldn't drive either forward or in reverse.At this stage, mrs.(b)(6) woke her husband up for help to operate the scooter and he then noticed white smoke emanating from the battery compartment and within seconds the battery pack burst into flames and it was only the scooter seat that prevented mrs.(b)(6) from getting burnt from these flames.Mrs.(b)(6) did not complain to the (b)(4) distributor of luggies until (b)(6) 2017.She has since released the burned-out scooter to us, but neither the battery nor the charger.Remark: (b)(6) accept the analysis and consider this issue closed on 7th of september, 2017.

• Brand Name: FREERIDER
• Type of Device: LUGGIE STANDARD
• Manufacturer (Section D): FREERIDER; no.22, bengong 5th rd.,; gangshan dist; kaohsiung 82059
• MDR Report Key: 7087888
• MDR Text Key: 94085918
• Report Number: 3008786141-2017-00001
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: LUG3ANRJBBACA3
• Was the Report Sent to FDA?: No
• Type of Device Usage: N
• Patient Sequence Number: 1