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MAUDE MDR 2356568

MDR report key
2356568
Report number
2356568
Event key
0
Event type
3
Date of event
2011-11-16
Date received
2011-11-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIODEX GIMBAL ASSEMBLYEXERCISER, POWEREDBIODEX MEDICAL SYSTEMS, INC.BXB820-120** Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-11-290

Event Narratives#

D

Patient 1

AT THE COMPLETION OF AN OUTPATIENT PHYSICAL THERAPY "BIODEX" TREATMENT, THE PHYSICAL THERAPY ASSISTANT (PTA) ATTEMPTED TO DISCONTINUE THE TREATMENT AND DISENGAGE THE PATIENT FROM THE MACHINE. THE MACHINE DID NOT SHUT OFF WHEN THE PTA ATTEMPTED TO SHUT IT OFF AND THE BIODEX ARM COMPRESSED DOWN ON THE PATIENT'S LEFT KNEE TEMPORARILY PINNING HER TO THE SEAT. NO APPARENT INJURY FROM INCIDENT. EMPLOYEE SUPERVISOR IDENTIFIED USER ERROR - NOT DEVICE MALFUNCTION - AS CAUSE OF INCIDENT.