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 further information or the device become available, a follow-up report will then be issued.

Event Description

Provider alleges consumer's wife alleges the remote stopped working and the consumer got stuck in the chair and had to call the fire department to get him out.

Manufacturer Narrative

The alleged loss of power could not be duplicated.

Event Description

Provider alleges consumer's wife alleges the remote stopped working and the consumer got stuck in the chair and had to call the fire department to get him out.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• MDR Report Key: 12122876
• MDR Text Key: 260115230
• Report Number: 2530130-2021-00072
• 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: 11/03/2021

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: 08/24/2021
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2021
• 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