CYBEX 2460 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-07-19 for CYBEX 2460 * manufactured by Cybex Div Of Lumex.

Event Text Entries

[250716] Pt was exercising on the ube when telescoping seat dropped to the lowest position. Knob used to secure post wasn't tightened when inspected.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1025677
• MDR Report Key: 407726
• Date Received: 2002-07-19
• Date of Report: 2002-07-19
• Date Added to Maude: 2002-07-31
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CYBEX
• Generic Name: UPPER BODY ERGOMETER
• Product Code: ISD
• Date Received: 2002-07-19
• Model Number: 2460
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 396709
• Manufacturer: CYBEX DIV OF LUMEX
• Manufacturer Address: 2100 SMITHTOWN AVE RONKONKOMA NY 117790903 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-07-19