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

Model Number	JAZZY 614HD
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/19/2018
Type of Reportable Event	Serious Injury
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 driving in his driveway when the back wheel caught on the stone lifting the chair enough that only one drive wheel was on the ground causing consumer to spin around in a circle and the chair tipped over and slid down a muddy hill ending up under a building.
Additional Manufacturer Narrative
A field service technician evaluated the device in the field.Customer went to go forward but hit reverse.Fst adjusted angle of joystick which was bent up at an angle due to the alleged incident.Unit is working properly.
Event or Problem Description
Alleges driving in his driveway when the back wheel caught on the stone lifting the chair enough that only one drive wheel was on the ground causing consumer to spin around in a circle and the chair tipped over and slid down a muddy hill ending up under a building.

• 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: 7911447
• Report Number: 2530130-2018-00132
• Device Sequence Number: 19194795
• Product Code: ITI
• UDI-Device Identifier: 00606509100052
• UDI-Public: 00606509100052
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K042612
• 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): 10/05/2018

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 614HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/09/2018
• 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