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

Model Number	JAZZY AIR
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The "date of event" was not provided.The device has not yet been made available for evaluation.If the device or further information becomes available, a follow-up report will then be issued.
Event or Problem Description
Alleges customer's feet do not fit on the footrest and therefore keeps crashing into the walls.
Additional Manufacturer Narrative
Allegation was that the customer's feet do not fit on the footrest causing him to crash into walls.The customer does not use the unit that often.He has brain damage and usually prefers to use a manual chair.Customer's wife stated the incident last december was minor and has not had any issues since.No further action needed at this time.
Event or Problem Description
Alleges customers feet do not fit on the foot rest and therefore keeps crashing into the walls.

• 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: 8161209
• Report Number: 2530130-2018-00178
• Device Sequence Number: 13854584
• Product Code: ITI
• UDI-Device Identifier: 00606509100069
• UDI-Public: 00606509100069
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143383
• 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): 11/12/2019

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 AIR
• 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: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 11/19/2019
• 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: Hospitalization