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	No Code Available (3191)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been made available for evaluation at this time.Should the device or more information become available, a follow-up report will then be issued.
Event or Problem Description
Provider alleges the consumer let go of the joystick, the unit kept moving, and allegedly pinned the consumer against his entertainment center.Consumer called 911.
Additional Manufacturer Narrative
The provider evaluated and repaired the device.The provider replaced the right motor and the device is working properly.Provider evaluated and repaired.
Event or Problem Description
Provider alleges the consumer let go of the joystick, the unit kept moving, and allegedly pinned the consumer against his entertainment center.Consumer called 911.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• MDR Report Key: 6371825
• Report Number: 2530130-2017-00024
• Device Sequence Number: 603663
• Product Code: ITI
• UDI-Device Identifier: 00606509100137
• UDI-Public: (01)00606509100137
• 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: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2017

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?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2017
• Supplement Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization