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 1997-07-25 for CYBEX NORM ISOKINETIC UNIT 771CF6-1 manufactured by Cybex.

Event Text Entries

[17178659] Pt was strapped on the cybex machine in the passive range of motion mode for left knee flexion and extension. When the machine was started it beat 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 Number112938
MDR Report Key112938
Date Received1997-07-25
Date of Report1997-03-10
Date of Event1997-03-07
Date Facility Aware1997-03-07
Report Date1997-03-12
Date Reported to Mfgr1997-03-12
Date Added to Maude1997-08-18
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameCYBEX NORM ISOKINETIC UNIT
Generic NameTESTING AND REHABILITATION SYSTEM
Product CodeIKK
Date Received1997-07-25
Model NumberNORM
Catalog Number771CF6-1
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Age10 MO
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key93640
ManufacturerCYBEX
Manufacturer Address2100 SMITHTOWN AVE P.O. BOX 9003 RONKONKOMA, LI, NY 117799003 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1997-07-25

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