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

Model Number LC358M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 03/18/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It is alleged the lift chair malfunctioned springing upright from a laid back position allegedly causing the consumer to slide onto a tile floor.

Event Description

It is alleged the lift chair malfunctioned springing upright from a laid back position allegedly causing the consumer to slide onto a tile floor.

Manufacturer Narrative

The "date of event" was removed.The "date of event" is unknown.The device has not been available for evaluation at this time.Should further information or the device become available, a follow-up report will then be issued.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• MDR Report Key: 10021268
• MDR Text Key: 189744441
• Report Number: 2530130-2020-00046
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400251
• UDI-Public: 00606509400251
• 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: 04/30/2020

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: LC358M
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/28/2020
• Initial Date FDA Received: 05/04/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death