MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number	JAZZY SELECT 6
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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "date of event" occurred sometime in (b)(6) 2021.The device has not yet been made available for evaluation.Should the device become available or further information become available, a follow-up report will then be issued.
Event or Problem Description
Consumer alleges they were going along a sidewalk and the chair allegedly kept going to the right when she allegedly went off a curb and fell out.
Additional Manufacturer Narrative
The device was returned for evaluation.There was a large chunk missing from the left front caster wheel and the programming was altered post final release as per exemplar check.Both of these conditions can affect device performance.However, it is impossible for the evaluator to definitively attribute either condition to the alleged event.The unit was equipped with a functioning lap belt and if worn the end-user would have stayed secured in the seat.The product literature (safety guide/owner's manual) includes language/warnings for programming, tire wear and wearing of a lap belt.The cause of the alleged event is unknown.
Event or Problem Description
Consumer alleges they were going along a sidewalk and the chair allegedly kept going to the right when she allegedly went off a curb and fell out.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• MDR Report Key: 11945957
• Report Number: 2530130-2021-00053
• Device Sequence Number: 1153570
• Product Code: ITI
• UDI-Device Identifier: 00606509100137
• UDI-Public: 00606509100137
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2021

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 SELECT 6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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