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

Model Number	Q6 EDGE
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Eye Injury (1845); Head Injury (1879); Pain (1994)
Date of Event	06/03/2020
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 while setting up device for end user, with end user in unit, the unit would not stop, and couldn't control the pwc, and it began to tip forwards after rolling 10 feet.Alleges the client then fell down in the stairs (4 steps in total) causing injury.
Additional Manufacturer Narrative
Only the head array was returned for evaluation.The evaluation concluded failure to follow setup warnings.
Event or Problem Description
Alleges while setting up new head array device for end user, with end user in unit, the unit would not stop, and couldn't control the pwc, and it began to tip forwards after rolling 10 feet.Alleges the client then fell down in the stairs (4 steps in total) causing injury.
Additional Manufacturer Narrative
Revised "describe event or problem" field.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 while setting up new head array device for end user, with end user in unit, the unit would not stop, and couldn't control the pwc, and it began to tip forwards after rolling 10 feet.Alleges the client then fell down in the stairs (4 steps in total) causing injury.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10128393
• Report Number: 2530130-2020-00055
• Device Sequence Number: 2152572
• Product Code: ITI
• UDI-Device Identifier: 00606509200028
• UDI-Public: 00606509200028
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 06/25/2020

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: Q6 EDGE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/03/2020; 06/03/2020
• Initial Report FDA Received Date: 06/08/2020
• Supplement Report FDA Received Date: 06/10/2020; 06/30/2020
• 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: Hospitalization