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

Model Number	J6
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been made available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.
Event or Problem Description
Alleges user was driving the chair, the joystick cable was hanging loose, dragging along the ground and got caught in the rear right caster wheel causing a fire, burned the right rear caster and joystick cable.
Additional Manufacturer Narrative
The device was returned and evaluated.The evaluator saw no evidence of fire.The joystick harness was damaged approximately 15" from the molex connect.There was evidence of high resistive shorting in this harness which likely contacted the right rear caster.The textual evidence (dragging along the ground) indicates customer misuse/improper provider setup as the cause of the damage.
Event or Problem Description
Alleges user was driving the chair, the joystick cable was hanging loose, dragging along the ground and got caught in the rear right caster wheel causing a fire, burned the right rear caster and joystick cable.

• 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: 8981385
• Report Number: 2530130-2019-00100
• Device Sequence Number: 3330723
• Product Code: ITI
• UDI-Device Identifier: 00606509100014
• UDI-Public: 00606509100014
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• 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): 10/11/2019

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: J6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/15/2019
• 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