MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS; POWERED WHEELCHAIR

Model Number JAZZY PASSPORT

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Concussion (2192)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Provider alleges consumer flipped backwards twice while on chair.

Manufacturer Narrative

The device was returned and evaluated.The alleged event could not be duplicated including on the maximum incline.

Event Description

Provider alleges consumer flipped backwards twice while on chair.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEELCHAIR
• MDR Report Key: 11863073
• MDR Text Key: 251932096
• Report Number: 2530130-2021-00047
• Device Sequence Number: 1
• Product Code: ITI
• UDI-Device Identifier: 00606509100212
• UDI-Public: 00606509100212
• Combination Product (y/n): N
• PMA/PMN Number: K011993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: JAZZY PASSPORT
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization