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

Model Number LC358XL

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleges chair has had several repairs.Alleges chair was just repaired a few days ago and had to call the fire department several times to get out of the chair since the chair is not working at all again.

Event Description

Alleges chair has had several repairs.Alleges chair was just repaired a few days ago and had to call the fire department several times to get out of the chair since the chair is not working at all again.

Manufacturer Narrative

The device has been made available for evaluation.The chair was rendered inoperable because of a damaged intermediate hand control harness.It is unknown how this damage occurred or if it's the original harness.Pinch/crush point warnings for wires already exist on pg 9 of the owner's manual.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• MDR Report Key: 12433681
• MDR Text Key: 271133152
• Report Number: 2530130-2021-00096
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400299
• UDI-Public: 00606509400299
• Combination Product (y/n): N
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

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?: 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: 09/29/2021
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 09/07/2021
• Supplement Dates Manufacturer Received: 09/01/2021
• Supplement Dates FDA Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2020
• 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