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 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

Provider alleges the chair failed when in the recline position and the consumer had to call the fire department to get them out of the chair.

Manufacturer Narrative

The returned lift chair was subjected to extreme misuse/abuse.This included damage to the hand control cord which resulted in a communication failure with the control box.The damage was visible and a repair was attempted instead of replacing the hand control.This type of abuse disregards the electronics care section of the owner's manual.

Event Description

Provider alleges the chair failed when in the recline position and the consumer had to call the fire department to get them out of the chair.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• MDR Report Key: 11347911
• MDR Text Key: 232527369
• Report Number: 2530130-2021-00017
• 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: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 06/09/2021
• Date Manufacturer Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• 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