FDA.reportPublic FDA data

MAUDE MDR 930442

MDR report key
930442
Report number
2918630-2007-00002
Event key
0
Event type
3
Date received
2007-10-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
KENT JONES
Address
5160 HACIENDA DRIVE DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1"HARK"AUTOMATIC REFRACTOR/KERATOMETORCARLA ZEISS MEDITEC INC.HKO599NYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-10-190

Event Narratives#

D

Patient 1

WHILE ADJUSTING THE TABLE HEIGHT, THE POWER CORD GOING TO THE PRODUCT ON THE TABLE TOP (HUMPHREY AUTOMATIC REFRACTOR/KERATOMETER) WAS CUT BY THE MOVING TABLE. THE CORD HAD BEEN COILED AROUND THE TABLE. THE POWER CORD SHORTED OUT AND SOME SPARKS WERE EMITTED WHICH CONTACTED THE TECHNICIAN, CAUSING MINOR PAIN. THE INSTRUMENT SHUT OFF.

N

Patient 1

THE POWER CORD AFFECTED WAS RETURNED TO CARL ZEISS MEDITEC FOR EVALUATION. A REPLACEMENT POWER CORD WAS SENT TO THE CUSTOMER.