MAUDE Adverse Event Report: PRIDE MOBILITY PRODUCTS PRIDE MOBILITY PRODUCTS; ELECTRIC POSITIONING CHAIR

Model Number LC358XL

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/01/2016

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

Dealer called and stated that the consumer alleges the chair started smoking so they called the fire department (911) who took the chair outside.

Manufacturer Narrative

The device was returned and evaluated.The evaluation determined the failure mode to be a diode on the pcb.

Event Description

Dealer called and stated that the consumer alleges the chair started smoking so they called the fire department (911) who took the chair outside.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• 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: 5428217
• MDR Text Key: 38474770
• Report Number: 2530130-2016-00014
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC358XL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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): Life Threatening