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

Model Number	JAZZY PASSPORT
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Event or Problem 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.
Additional 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 webtrader license.There were a series of difficulties in getting this licence and numberous e-mails were sent to the fda helpdesk.A follow-up report will be forthcoming if more information becomes awailable.Device evaluaton: device sustained thermal event in battery pack.Although the exact cause could not be determined, third party testing was performed on a current battery production battery pack in which the event could not be duplicated.The passport will be discontinued at the end of the ear and is being replaced with an new model and battery pack.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: 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
• Report Number: 2530130-2023-00177
• Device Sequence Number: 15056889
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011993
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: JAZZY PASSPORT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 10/13/2023
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male