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

Model Number LC580IM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Alleges the back broke when consumer was in the process of raising the chair to get out of it.

Manufacturer Narrative

The returned lift chair was subjected to extreme abuse/misuse.The chair's articulation had nothing to do with the back breaking.The seat back appeared to have been stapled and glued correctly.The abuse/misuse included but was not limited to liquid ingress, operating against an obstruction and excessive force on the back.This pattern of abuse likely led to the back breaking.

Event Description

Alleges the back broke when consumer was in the process of raising the chair to get out of it.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• MDR Report Key: 11796069
• MDR Text Key: 249664455
• Report Number: 2530130-2021-00039
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400770
• UDI-Public: 00606509400770
• Combination Product (y/n): N
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC580IM
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2021
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2018
• 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): Hospitalization