MAUDE Adverse Event Report: ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTDZHE PRIDE MOBILITY PRODUCTS; WHEELCHAIR, POWERED

Model Number	JAZZY CARBON
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	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Provider alleges the consumer was sitting in the chair and when he stood to transfer out of the carbon, he allegedly saw sparks then the chair allegedly caught fire.
Additional Manufacturer Narrative
Notified the manufacturer of record of the incident.Site visit coulde not concule the device was the casue of the event.However, complete device was not made available.Report on file and sent to the manufacturer of record.
Additional Manufacturer Narrative
Site visit could have not conclude the device was the cause of the event.However, a complete device was not made available.Report on file and sent to the manufacturer of record.Additional information: not a pride issue.Provider informed rep the consumer caught the chair on fire with a cigarette and walked into the store a little later and bought a gochair.Didn't want lithium anymore.
Event or Problem Description
Provider alleges the consumer was sitting in the chair and when he stood to transfer out of the carbon, he allegedly saw sparks then the chair allegedly caught fire.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: WHEELCHAIR, POWERED
• Manufacturer (Section D): ZHEJIANG INNUOVO REHABILITATION DEVICES CO.,LTDZHE; no.196 industry road, hengdian; movie zone; dongyang, zhejiang ; CH
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: maggie lyu ; no.196 industry road, hengdian movie zone; dongyang, zhejiang ; CH
• MDR Report Key: 20015793
• Report Number: 2530130-2024-00538
• Device Sequence Number: 8675172
• Product Code: ITI
• UDI-Device Identifier: 00606509100311
• UDI-Public: 00606509100311
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K220747
• 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): 07/15/2025

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 CARBON
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2023
• 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