MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS 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	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not made available for evaluation at this time.Should further information or the device become available, a follow-up report will be issued.
Event or Problem Description
Provider alleges issues with the motors allegedly caused the unit to come to a stop throwing the consumer out.
Additional Manufacturer Narrative
The motors were returned for evaluation.The alleged condition (sudden stop) could not be duplicated.(b)(4).
Event or Problem Description
Provider alleges issues with the motors allegedly caused the unit to come to a stop throwing the consumer out.
Event or Problem Description
Provider alleges issues with the motors allegedly caused the unit to come to a stop throwing the consumer out.
Additional Manufacturer Narrative
The motors were returned and evaluated previously.The alleged condition (sudden stop) could not be duplicated via functional testing.The consumer alleges the unit was still not operating properly after the motor replacement.The entire device was then returned and evaluated.The evaluation concluded that the new motors were not installed properly by the provider.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 10264123
• Report Number: 2530130-2020-00068
• Device Sequence Number: 19419435
• Product Code: ITI
• UDI-Device Identifier: 00606509100137
• UDI-Public: 00606509100137
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/18/2020

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: 09/25/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020; 07/09/2020
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 08/10/2020; 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization