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

Model Number Q6 EDGE 2.0

Device Problem Unintended Movement (3026)

Patient Problem Hip Fracture (2349)

Event Date 03/30/2020

Event Type  Injury  

Manufacturer Narrative

Provider replaced motors after doing an evaluation of the unit.The unit was working properly and any alleged issues the consumer is having is consumer error.

Event Description

Consumer alleges unit took off on its own and he was allegedly thrown form the chair and pinned down.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• Manufacturer (Section G): N/A; n/a; n/a; n/a,
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, pa ; 6024056
• MDR Report Key: 10178866
• MDR Text Key: 195923461
• Report Number: 2530130-2020-00058
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509200042
• UDI-Public: 00606509200042
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/18/2020

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
• Device Operator: Lay User/Patient
• Device Model Number: Q6 EDGE 2.0
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 06/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization