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

Model Number LC250

Device Problems Fire (1245); Smoking (1585); Sparking (2595)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 07/31/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Alleges the hand control caught fire.Alleges she was pushing the buttons to get out of the chair when it started smoking and sparking, then caught fire.

Manufacturer Narrative

The device was returned and evaluated.Misuse-failure to periodically check hand control for damage.The root cause of the failure appears to be a damaged harness.The operation precautions in the manual instructs to periodically check the hand control and all power cords for visible damage.

Event Description

Alleges the hand control caught fire.Alleges she was pushing the buttons to get out of the chair when it started smoking and sparking, then caught fire.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 12259143
• MDR Text Key: 264497162
• Report Number: 2530130-2021-00084
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400237
• UDI-Public: 00606509400237
• Combination Product (y/n): N
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC250
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 08/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other