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

Model Number LC250

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/08/2021

Event Type  malfunction  

Event Description

Provider alleges, consumer alleges, the cord allegedly caught on fire.

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 Description

Provider alleges, consumer alleges, the cord allegedly caught on fire.

Manufacturer Narrative

The hand control harness was damaged 12" and 18" from the connector end.There was evidence of exposed wiring but no evidence of fire or shorting.The chair was still functional despite this damage.The hand control harness was damage due to customer abuse.The owner's manual contains instruction to periodically check the hand control harnessing for damage.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• 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 ave; duryea, PA 18642 ; 8008008586
• MDR Report Key: 12983291
• MDR Text Key: 282382236
• Report Number: 2530130-2021-00133
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400237
• UDI-Public: 00606509400237
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 01/19/2022
• Date Manufacturer Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2021
• 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 Sex: Female