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

Model Number TMR560

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Consumer alleges the chair rose up on it's own and she got stuck in the chair and had to call 911 to get out of the chair.She also alleges the motor was hot to the touch.

Manufacturer Narrative

The device was returned and evaluated.The unintended motion could not be duplicated.

Event Description

Consumer alleges the chair rose up on it's own and she got stuck in the chair and had to call 911 to get out of the chair.She also alleges the motor was hot to the touch.

• 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: 9825804
• MDR Text Key: 189746943
• Report Number: 2530130-2020-00032
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• PMA/PMN Number: K953342
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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: TMR560
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other