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

Model Number SC613 LUNA VICTORY

Device Problems Smoking (1585); Appropriate Term/Code Not Available (3191)

Patient Problem Aspiration/Inhalation (1725)

Event Date 07/06/2021

Event Type  Injury  

Manufacturer Narrative

The "patient identifier", "date of event", "model #", "serial #", and "device manufacture date" have not been provided.Should further information or the device become available, a follow-up report will then be issued.

Event Description

Alleges scooter stops, smoke from controller.Alleges after driving 10 meters, the scooter stops and does nothing more.Scooter was checked and as soon as the batteries were connected, the controller starts to smoke and stink.Disconnected batteries again.

Manufacturer Narrative

The "model #", "serial #", "unique identifier (udi) number" and "device manufacture date" have been updated.Should further information or the device become available, a follow-up report will then be issued.

Event Description

Alleges scooter stops, smoke from controller.Alleges after driving 10 meters, the scooter stops and does nothing more.Scooter was checked and as soon as the batteries were connected, the controller starts to smoke and stink.Disconnected batteries again.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: MOTORIZED THREE-WHEELED VEHICLE
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 12391978
• MDR Text Key: 268934001
• Report Number: 2530130-2021-00094
• Device Sequence Number: 1
• Product Code: INI
• Combination Product (y/n): N
• PMA/PMN Number: K092088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: SC613 LUNA VICTORY
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization