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

Model Number LC525IM

Device Problem Fire (1245)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The customer discarded the hand control.The remainder of 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

Alleges being reclined back in the chair when she smelled something burning and alleges the hand control caught on fire.Alleges she yanked the control from the chair and threw it outside and roommate threw the hand control away.

Manufacturer Narrative

Only the lift chair frame and motor were returned for evaluation.As stated in the text, the hand control was disposed of by the consumer's roommate and there was no evidence of fire on the two components that were returned.

Event Description

Alleges being reclined back in the chair when she smelled something burning and alleges the hand control caught on fire.Alleges she yanked the control from the chair and threw it outside and roommate threw the hand control away.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea PA 18642
• Manufacturer (Section G): N/A; n/a; n/a; n/a
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, PA 18642 ; 5706024056
• MDR Report Key: 8473967
• MDR Text Key: 140635721
• Report Number: 2530130-2019-00034
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400107
• UDI-Public: 00606509400107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LC525IM
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2019
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other