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

Model Number	JAZZY ELITE HD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The "date of event" has not been provided.The device has not yet been made available for evaluation.Should further information or the device become available for evaluation, a follow-up report will then be issued.
Event or Problem Description
Alleges customer got stuck outside and had to have fire department move customer inside.Customer also alleges the chair stops even when riding indoors on flat surface and claims he fell halfway off trying to transfer out of unit.Unit does not hold a charge.
Additional Manufacturer Narrative
The device was returned and evaluated.Although the battery brand used (power king) was not supplied or qualified by pride, the batteries appeared to hold charge and deplete at a normal rate over 3 hours of constant use.The text of the complaint does not indicate the device as the cause of the alleged fall during the transfer.
Event or Problem Description
Alleges customer got stuck outside and had to have fire department move customer inside.Customer also alleges the chair stops even when riding indoors on flat surface and claims he fell halfway off trying to transfer out of unit.Unit does not hold a charge.

• 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: 8607685
• Report Number: 2530130-2019-00053
• Device Sequence Number: 19375572
• Product Code: ITI
• UDI-Device Identifier: 00606509100113
• UDI-Public: 00606509100113
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112815
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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 HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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: Other