MAUDE Adverse Event Report: GF HEALTH PRODUCTS, INC. LUMEX; CHAIR, ADJUSTABLE, MECHANICAL

Model Number 7921A-4

Patient Problem Fall (1848)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

Situation: patient was showering, leg of shower chair bent.There was no patient injury.Weight limit of the chair is 350 lbs.The patient that fell was approx.85 lbs.There is a barcode with this number underneath it: (b)(4).There is another sticker that says item number: 7921a-4.

• Brand Name: LUMEX
• Type of Device: CHAIR, ADJUSTABLE, MECHANICAL
• Manufacturer (Section D): GF HEALTH PRODUCTS, INC.; 1 graham field way; atlanta GA 30340
• MDR Report Key: 18491267
• MDR Text Key: 332614279
• Report Number: 18491267
• Device Sequence Number: 1
• Product Code: INN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 7921A-4
• Device Catalogue Number: 7921A-4
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1