FDA.reportPublic FDA data

MAUDE MDR 4122291

MDR report key
4122291
Report number
1000404456-2014-00008
Event key
0
Event type
3
Date of event
2014-09-04
Date received
2014-09-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. KATHRYN CADORETTE
Address
5960 HEISLEY ROAD MENTOR OH 44060 US
Phone
440-440-4403
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HARMONY IQ 3600 INTEGRATION SYSTEMINTEGRATION SYSTEMVTS MEDICAL SYSTEMSLMDY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-09-260

Event Narratives#

D

Patient 1

THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE MONITOR BLANKED OUT AND CONTINUED TO BLINK DURING THE CASE. A REPLACEMENT MONITOR WAS BROUGHT INTO THE ROOM AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO INJURIES WERE REPORTED.

N

Patient 1

THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

N

Patient 1

A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY, INSPECTED THE INTEGRATION SYSTEM AND DETERMINED THE ISSUE WAS CAUSED BY THE CAMERA UTILIZED AT THE TIME OF THE EVENT. THE TECHNICIAN MADE THE NECESSARY ADJUSTMENTS, TESTED THE INTEGRATION SYSTEM AND CONFIRMED THE UNIT WAS OPERATING TO SPECIFICATION.