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

Model Number LC580IL

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Bone Fracture(s) (1870)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Customer was operating the lift chair with the hand control when the chair allegedly fell on top of him and he became pinned beneath the chair resulting in injuries.

• Brand Name: PRIDE MOBILITY PRODUCTS
• Type of Device: ELECTRIC POSITIONING CHAIR
• Manufacturer (Section D): PRIDE MOBILITY PRODUCTS; 401 york ave; duryea, pa
• Manufacturer (Section G): N/A; n/a; n/a; n/a,
• Manufacturer Contact: kelly livingston ; 401 york ave; duryea, pa ; 6024056
• MDR Report Key: 10264120
• MDR Text Key: 198521418
• Report Number: 2530130-2020-00066
• Device Sequence Number: 1
• Product Code: INO
• UDI-Device Identifier: 00606509400787
• UDI-Public: 00606509400787
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/08/2020

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: LC580IL
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2018
• 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): Hospitalization