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

Model Number PLR975M

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Alleges base motor is barely working, and sounds like something inside the box is grinding.Alleges had to call the fire department to get user out of the chair.

Manufacturer Narrative

Only the base actuator was returned for evaluation.The alleged condition could not be duplicated.

Event Description

Alleges base motor is barely working and sounds like something inside the box is grinding.Alleges had to call the fire department to get user 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: 10661037
• MDR Text Key: 210810803
• Report Number: 2530130-2020-00093
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400930
• UDI-Public: 00606509400930
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: PLR975M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other