FDA.reportPublic FDA data

MAUDE MDR 8280867

MDR report key
8280867
Report number
3003781275-2019-00001
Event key
0
Event type
3
Date of event
2019-01-15
Date received
2019-01-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KEVIN WALLS
Address
33 GOLDEN EAGLE LANE LITTLETON CO 80127 US
Phone
720-720-7209
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LOKOMATSYSTEM, ISOKINETIC TESTING AND EVALUATIONHOCOMA AGIKKLOKOMATPRO L6.128862Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-01-280

Event Narratives#

N

Patient 1

THE BROKEN ROPE WAS SENT BACK TO THE MANUFACTURER FOR EXAMINATION. RESULT OF THE EXAMINATION WAS THAT THE DEFECT WAS CAUSED BY WRONG INSERTION OF THE ROPE AFTER REPLACEMENT. THE DEVICE HAD BEEN MOVED BY HOCOMA SERVICE TECHNICIAN ONE WEEK BEFORE THIS EVENT. THE ROPE HAS BEEN INSTALLED ACROSS A METAL BAR INSTEAD OF BEING PULLED THROUGH A FEEDTHROUGH UNDERNEATH THIS BAR. AS A RESULT OF THIS INCREASED FRICTION, THE ROPE BROKE SOON AFTER TAKING THE DEVICE INTO SERVICE AGAIN.

D

Patient 1

AT THE END OF THE TRAINING SESSION, THE PATIENT IS LIFTED TO BE TAKEN OUT OF THE DEVICE. BODY WEIGHT SUPPORT ROPE BREAKS WHILE LIFTING PATIENT UP. PATIENT (M, (B)(6) YR, (B)(6) KG) DROPS SLIGHTLY. IS CAUGHT BY CLINICIAN AND PUSHED UP. TWO OTHER CLINICIANS CAME TO HELP. PATIENT SUFFERED NO INJURY.