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

Model Number LC358L

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 04/10/2021

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

Provider alleges consumer got stuck in the recline position and had to call the paramedics to get him out of the chair.

Manufacturer Narrative

Only the actuator was returned for evaluation.The actuator failed to reach full extension during load testing and would not retract.This functional failure was identified as a worm gear failure.It is unknown what caused this gear to fail.

Event Description

Provider alleges consumer got stuck in the recline position and had to call the paramedics to get him out of the chair.

• 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: 11677845
• MDR Text Key: 247975410
• Report Number: 2530130-2021-00032
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400244
• UDI-Public: 00606509400244
• 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: 04/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC358L
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2021
• Date Manufacturer Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other