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

Model Number LC358XXL

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

Event Description

Provider alleges the consumer was reclining back and the lift chair allegedly did not stop.The consumer allegedly heard a crack.

Manufacturer Narrative

The device was returned and evaluated.The seat box was found to be fractured during the evaluation.Possible misuse by operating device against an obstruction or transferring to a bed via the seat back.

Event Description

Provider alleges the consumer was reclining back and the lift chair allegedly did not stop.The consumer allegedly heard a crack.

• 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: 11223835
• MDR Text Key: 228712104
• Report Number: 2530130-2021-00007
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400305
• UDI-Public: 00606509400305
• 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: 03/25/2021

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: LC358XXL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Initial Date Manufacturer Received: 01/18/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other