MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number JAZZY 614HD

Device Problems Fire (1245); Smoking (1585)

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

Event Type  malfunction  

Manufacturer Narrative

The "date of event" was not provided.The device has not yet been made available for evaluation.If the device or further information becomes available, a follow-up report will then be issued.

Event Description

Alleges chair was charging when he smelled smoke and he noticed it coming from the controller on his chair.Alleges he unplugged the charger and took the controller off of the chair to take it outside.Alleges as he was taking it outside, it caught on fire.Alleges throwing it in his yard and pouring water on it.

Manufacturer Narrative

A returned product evaluation was conducted and the thermal event was not related to the product.

Event Description

Alleges chair was charging when he smelled smoke and he noticed it coming from the controller on his chair.Alleges he unplugged the charger and took the controller off of the chair to take it outside.Alleges as he was taking it outside, it caught on fire.Alleges throwing it in his yard and pouring water on it.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 5706024056
• MDR Report Key: 8119642
• MDR Text Key: 128881252
• Report Number: 2530130-2018-00169
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100052
• UDI-Public: 00606509100052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY 614HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Date Manufacturer Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other