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

Model Number Q600

Device Problems Entrapment of Device (1212); Fire (1245)

Patient Problem Injury (2348)

Event Date 06/29/2015

Event Type  Injury  

Event Description

Dealer alleges consumer got wedged within a door frame and continued to drive it forward creating a heat source.Dealer alleges device caught fire and user remained trapped in device sustaining injuries.

Manufacturer Narrative

The unit was bought second hand.The device has not been made available for evaluation at this time.Should further information or the device become available for evaluation, a follow-up report will then be issued.

Manufacturer Narrative

The device was returned and evaluated.During the evaluation, an unauthorized modification of the device was found.

Event Description

Dealer alleges consumer got wedged within a door frame and continued to drive it forward creating a heat source.Dealer alleges device caught fire and user remained trapped in device sustaining injuries.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: POWERED WHEECHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 182 susquehanna ave; n/a; exeter PA 18643
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 182 susquehanna ave; n/a; exeter, PA 18643 ; 5706555574
• MDR Report Key: 4915340
• MDR Text Key: 6027573
• Report Number: 2530130-2015-00057
• Device Sequence Number: 1
• Product Code: ITI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K042612
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: Q600
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization