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

Model Number	QUNATUM RIVAL R44
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2020
Type of Reportable Event	Malfunction
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
Provider alleges the consumer's unit allegedly shut off and threw him from the unit.
Event or Problem Description
Provider alleges the consumer's unit allegedly shut off and threw him from the unit.
Additional Manufacturer Narrative
Provider stated that the end user said that he drives his chair consistently all day long and the chair died due to normal usage.Provider tested the batteries, checked all harnesses and connections, and everything was working properly.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10128395
• Report Number: 2530130-2020-00056
• Device Sequence Number: 2152571
• Product Code: ITI
• UDI-Device Identifier: 00606509200134
• UDI-Public: 00606509200134
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K011993
• 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): 06/17/2020

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: QUNATUM RIVAL R44
• 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: 05/29/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/22/2020
• 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