FDA.reportPublic FDA data

MAUDE MDR 5515915

MDR report key
5515915
Report number
5515915
Event key
0
Event type
3
Date of event
2015-10-29
Date received
2016-03-22
Adverse event
0
Product problem
3
Patients in event
0
Reporter occupation
0
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
1LOKOMATSYSTEM, ISOKINETIC TESTING AND EVALUATIONREGULATORY INSIGHT, INC.IKKLOKOMAT PRONANAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-03-220

Event Narratives#

N

Patient 1

D

Patient 1

PATIENT WAS REMOVED FROM THE EQUIPMENT, AND HOCOMA SUPPORT WAS CONTACTED. SUPPORT WALKED WRITER THROUGH A CALIBRATION PROCESS. THE PATIENT WAS AGAIN SET UP IN THE LOKOMAT, AND GAIT TRAINING WAS INITIATED. WITHIN 5 MIN OF STARTING TRAINING, THE LOKOMAT PC ALERTED THE USER THAT IT WAS "REBOOTING NOW". THE MACHINE SHUT DOWN WITH THE PATIENT ON THE TREADMILL WITHIN THE ROBOTIC SYSTEM. THE TWO ABOVE LISTED WITNESSES WERE CALLED TO ASSIST WITH REMOVAL OF THE PATIENT FROM THE SYSTEM. THE MANUAL/EMERGENCY RELEASE OF THE OVERHEAD HARNESS SYSTEM WAS INITIATED, BUT IT REQUIRED THE ADDITION OF WRITER'S WEIGHT ON THE HANGER/PULLEY IN ORDER TO LOWER THE PATIENT TO HIS WHEELCHAIR. THE SYSTEM WOULD NOT LOWER COMPLETELY TO THE WHEELCHAIR SEAT, BUT DISMOUNT WAS ABLE TO BE ACHIEVED WITH THE USE OF THE SEAT ELEVATOR FUNCTION ON THE PATIENT'S WHEELCHAIR. THE LOKOMAT SYSTEM COULD NOT BE RESTARTED ON THIS DAY. ====================== MANUFACTURER RESPONSE FOR EXERCISER, EXERCISER (PER SITE REPORTER) ====================== UNKNOWN. COMPANY IS AWARE OF ONGOING ISSUES.