CYBEX NORM ISOKINETIC UNIT 771CF6-1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-05-28 for CYBEX NORM ISOKINETIC UNIT 771CF6-1 manufactured by Cybex.

Event Text Entries

[63029] Pt was strapped on the co machine in the passive range of motion mode for left knee flexion and extension. When the machine was started it bent the pt's left knee back into flexion further than the anticipated range of motion before the emergency stop control could be activated. The mechanical stops were not set.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2432357-1997-00002
• MDR Report Key: 94834
• Date Received: 1997-05-28
• Date of Report: 1997-03-10
• Date of Event: 1997-03-07
• Date Facility Aware: 1997-03-07
• Report Date: 1997-03-12
• Date Reported to Mfgr: 1997-03-12
• Device Manufacturer Date: 1996-06-01
• Date Added to Maude: 1997-06-03
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: PHYSICAL THERAPIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Remedial Action: OT
• Previous Use Code: 3
• Removal Correction Number: NA
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CYBEX NORM ISOKINETIC UNIT
• Generic Name: TESTING AND REHABILITATION SYSTEM
• Product Code: IKK
• Date Received: 1997-05-28
• Model Number: NORM
• Catalog Number: 771CF6-1
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 10 MO
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 93640
• Manufacturer: CYBEX
• Manufacturer Address: 2100 SMITHTOWN AVE. P.O. BOX 9003 RONKONKOMA NY 117799003 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1997-05-28