MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; MOTORIZED THREE-WHEELED VEHICLE

Model Number	S54LX GO GO LX 4 WHEEL
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges end user put batteries on to charge overnight, plugged into wall outlet and woke up to a smoke filled room.Fire department was called.
Additional Manufacturer Narrative
The charger was returned and evaluated.The charger did not smell of smoke.The charger and its harnessing showed no evidence of being damaged.The charger was tested on a slave unit and did not emit any smoke.The charger went through the charging stages normally.
Event or Problem Description
Provider alleges end user put batteries on to charge overnight, plugged into wall outlet and woke up to a smoke filled room.Fire department was called.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 9193227
• Report Number: 2530130-2019-00116
• Device Sequence Number: 3730955
• Product Code: INI
• UDI-Device Identifier: 00606509300360
• UDI-Public: 00606509300360
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K063389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: S54LX GO GO LX 4 WHEEL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2019
• Supplement Date Received by Manufacturer: 10/09/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 11/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other