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

Model Number JAZZY J4HD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abrasion (1689)

Event Date 07/12/2022

Event Type  Injury  

Manufacturer Narrative

The device has not been made available for evaluation.Should further information of the device become availabe, a follow-up report will be issued.

Event Description

Provider alleges consumer got stuck going up a 25% or higher hill and the unit allegedly locked.The fire department came to release the motor brakes.Then the unit allegedly spun out of control and the consumer allegedly flipped in the chair on its side.

Manufacturer Narrative

The evaluator was not able to duplicate the inoperable on a hill claim at the rated angle, component failure.

Event Description

Provider alleges consumer got stuck going up a 25% or higher hill and the unit allegedly locked.The fire department came to release the motor brakes.Then the unit allegedly spun out of control and the consumer allegedly flipped in the chair on its side.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 8008008586
• MDR Report Key: 15198297
• MDR Text Key: 297588219
• Report Number: 2530130-2022-00071
• Device Sequence Number: 1
• Product Code: ITI
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY J4HD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male