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

Model Number LC105

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleges consumer was lifting out of chair when it reclined all the way on its own and got stuck.Alleges consumer had to call fire department to get out of chair.

Event Description

Alleges consumer was lifting out of chair when it reclined all the way on its own and got stuck.Alleges consumer had to call fire department to get out of chair.

Manufacturer Narrative

Only the hand control was returned.Functional and electrical testing revealed the db2 subminiature switch on the hand control's pcb that controls the recline function failed.It is unknown why this component failed.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• MDR Report Key: 11760891
• MDR Text Key: 248542382
• Report Number: 2530130-2021-00035
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400145
• UDI-Public: 00606509400145
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC105
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other