MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number	JAZZY ELITE 14
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "date of event" was reported as occurring in (b)(6) of 2020.The device has not been made available for evaluation.Should the device or further information become available, a follow-up report will then be issued.
Event or Problem Description
Alleges customer was thrown from device when it cut out and stopped.
Event or Problem Description
Alleges customer was thrown from device when it cut out and stopped.
Additional Manufacturer Narrative
The alleged loss of power could not be duplicated.The device was equipped with a functioning lap belt.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• MDR Report Key: 12031448
• Report Number: 2530130-2021-00062
• Device Sequence Number: 1001132
• Product Code: ITI
• UDI-Device Identifier: 00606509100076
• UDI-Public: 00606509100076
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K092961
• 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): 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: JAZZY ELITE 14
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 09/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• 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
• Outcome Attributed to Adverse Event: Hospitalization