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

Model Number	LC358S
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been made available for evaluation.Should further information of the device become available, a follow-up report will be issued.
Event or Problem Description
Provider alleges the hand control burst into flames.
Additional Manufacturer Narrative
The root cause of the failure appears to be a damaged strain relief which caused the harness to fail; the pcb works as intended.The product literature contains instruction to periodically check the hand control for visible damage.Note: when attempting to file a follow-up on this file, complaint #(b)(4), 2530130-2023-0002, i found this file was not in the esubmitter file system.I began to reseach this mdr.I had acknowledgement receipts as passing and i found the mdr registered in maude but still could not find the file in the esubmitter.With further research in webtrader, i identifed the following: on (b)(6) 2023, the submitter results produced "pass" at 13:29:59 est however, on (b)(6) 2023, the submitter results produced "fail" at 13:31:31 est.As a result, the emdr was not tranmsitted.I have now submitted this follow-up to explain the situation above and add the product evaluation.
Event or Problem Description
Provider alleges the hand control burst into flames.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Common Device Name: 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: 16122465
• Report Number: 2530130-2023-00002
• Device Sequence Number: 6533350
• Product Code: INO
• UDI-Device Identifier: 00606509400282
• UDI-Public: 00606509400282
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K070950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: LC358S
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 12/29/2022
• Initial Report FDA Received Date: 01/09/2023
• Supplement Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female