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

Model Number CL10KD

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Injury (2348); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/31/2019

Event Type  Injury  

Manufacturer Narrative

The "model #" and "serial #" have not been provided.The device was not made available for evaluation at this time.Should further information or the device become available, a follow-up report will be issued.

Event Description

Alleges without any warning and without anyone operating the remote control, the lift chair lifted up and dropped her out.

Manufacturer Narrative

"model #", "serial #", "unique identifier (di) #", and "device manufacture date" were updated.An inspection occurred with expert.There were no electrical issues with the product.

Event Description

Alleges without any warning and without anyone operating the remote control, the lift chair lifted up and dropped her out.

• 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: 10328263
• MDR Text Key: 200481597
• Report Number: 2530130-2020-00072
• Device Sequence Number: 1
• Product Code: INO
• Combination Product (y/n): N
• PMA/PMN Number: K070950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: CL10KD
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization