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

Model Number LZ226822320S20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Provider alleges the consumer allegedly smelled smoke while sitting in the radiance, but couldn't identify where it was coming from - the consumer allegedly found the chair on fire shortly after this, dragged it outside where it allegedly became engulfed in flames.

Event Description

Provider alleges the consumer allegedly smelled smoke while sitting in the radiance, but couldn't identify where it was coming from - the consumer allegedly found the chair on fire shortly after this, dragged it outside where it allegedly became engulfed in flames.

Manufacturer Narrative

Remnant harnessing was examined and no evidence of arcing was found.With this, the origin of the event is unknown.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: CHAIR, POSITIONING, ELECTRIC
• 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 avenue; duryea, PA 18642 ; 8008008586
• MDR Report Key: 18181247
• MDR Text Key: 328626974
• Report Number: 2530130-2023-00219
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509401500
• UDI-Public: 00606509401500
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091578
• 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: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LZ226822320S20
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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): Other
• Patient Sex: Male