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

Model Number JAZZY SELECT 6

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The device was not made available for evaluation at this time.Should further information or the device become available, a follow-up report will be issued.

Event Description

Provider alleges issues with the motors allegedly caused the unit to come to a stop throwing the consumer out.

Manufacturer Narrative

The motors were returned for evaluation.The alleged condition (sudden stop) could not be duplicated.(b)(4).

Event Description

Provider alleges issues with the motors allegedly caused the unit to come to a stop throwing the consumer out.

Event Description

Provider alleges issues with the motors allegedly caused the unit to come to a stop throwing the consumer out.

Manufacturer Narrative

The motors were returned and evaluated previously.The alleged condition (sudden stop) could not be duplicated via functional testing.The consumer alleges the unit was still not operating properly after the motor replacement.The entire device was then returned and evaluated.The evaluation concluded that the new motors were not installed properly by the provider.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 10264123
• MDR Text Key: 198521410
• Report Number: 2530130-2020-00068
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100137
• UDI-Public: 00606509100137
• Combination Product (y/n): N
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY SELECT 6
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2020
• Date Manufacturer Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization