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

Model Number JAZZY PASSPORT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/10/2023

Event Type  malfunction  

Manufacturer Narrative

The charger was tested and found to be confirming.The battery pack will be evaluated by the manufacturer.A follow-up report will be forthcoming if more information becomes available.This mdr is beyond the 30-day requirement due to the fda requiring a new web trader license.There were a series of difficulties in getting this licence and numberous e-mails were sent to the fda help desk.A follow-up report will be forthcoming if more information becomes available.

Event Description

Consumer alleges he smelled smoke and went to check his chair that was charging.He alleges the battery charger light was green, so he unplugged the charger cord from the chair, he allegedly heard a faint clicking sound allegedly coming from under the chair.When he looked at the chair he alleges smoke started to billow out, the battery allegedly started hissing and flames allegedly began to shoot out to about 4-6 inches in at least two directions.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: WHEELCHAIR, POWERED
• 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 avenue; duryea, PA 18642 ; 8008008586
• MDR Report Key: 17930516
• MDR Text Key: 325607391
• Report Number: 2530130-2023-00177
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K011993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY PASSPORT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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 Sex: Male