FDA.reportPublic FDA data

MAUDE MDR 4329071

MDR report key
4329071
Report number
2918630-2014-00001
Event key
0
Event type
3
Date of event
2014-10-13
Date received
2014-11-19
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
JUDY BRIMACOMBE
Address
5160 HACIENDA DR. DUBLIN CA 94568 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1POWER TABLETABLE INSTRUMENT POWERED OPHTHALMICCARL ZEISS MEDITEC INCHRJHFA 1202660021124421Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-11-190

Event Narratives#

D

Patient 1

A PERIMETER AND POWER TABLE HFA 120 WERE SET UP AT A CUSTOMER SITE BY A CONTRACTOR IN PREPARATION FOR ON-SITE STAFF TRAINING BY THE MANUFACTURER'S CLINICAL APPLICATIONS SPECIALIST. A FIELD SERVICE ENGINEER, ON-SITE FOR A DIFFERENT REASON, NOTICED THAT THE POWER TABLE WAS WOBBLY. HE INSPECTED THE TABLE AND DETERMINED THAT THERE WAS A PROBLEM WITH THE WELD JOINING THE COLUMN TO THE BASE.

N

Patient 1

(B)(6).

N

Patient 1

ADDED MANUFACTURER NARRATIVE: A QUALITY ENGINEER (QE) PERFORMED AN IN-HOUSE INSPECTION OF THE POWER TABLE. THE QE FOUND THAT THE TABLE WAS MISSING A SOLDERING WELD SPECIFIED BY THE DESIGN. THE MANUFACTURER REPLACED THE TABLE AT THE CUSTOMER SITE. CORRECTION: ON INITIAL REPORT SHOULD HAVE BEEN "11/19/2014" INSTEAD OF "10/19/2014". UPDATE: METHOD AND CONCLUSIONS.

D

Patient 1

NA