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

Model Number	JAZZY ELITE ES
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/03/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not yet 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 consumer suffered some symptoms which limited her mobility and the use of the device, she fell, and could not get herself back up.
Event or Problem Description
Alleges consumer suffered some symptoms which limited her mobility and the use of the device, she fell, and could not get herself back up.
Additional Manufacturer Narrative
The device was returned and evaluated.The text of the complaint does not attribute the alleged event to the returned device.The returned device was in new condition, fully functional, and the seat was equipped with a lap belt.With this, there was nothing with the design or functionality of the device that could be associated with the text.

• 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: 9341146
• Report Number: 2530130-2019-00129
• Device Sequence Number: 2734102
• Product Code: ITI
• UDI-Device Identifier: 00606509100083
• UDI-Public: 00606509100083
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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 ELITE ES
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 02/05/2020
• 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: Death