HARMONY IQ CUSTOM INTEGRATION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-11-06 for HARMONY IQ CUSTOM INTEGRATION SYSTEM manufactured by Vts Medical Systems.

Event Text Entries

[4976485] The user facility reported that during a patient procedure the touch panel and field monitors were displaying images from the nurse's personal computer. No injuries were reported however, a procedural delay occurred due to the reported event.
Patient Sequence No: 1, Text Type: D, B5


[12600795] Investigation of this event is currently in process. A follow-up report will be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10


[30056890] A steris service specialist arrived at the facility, inspected and tested the integration system and was able to duplicate the reported issue. The technician performed the necessary repairs, tested the system and placed it back into service.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1000404456-2014-00011
MDR Report Key4232424
Report Source06
Date Received2014-11-06
Date of Report2014-11-06
Date of Event2014-10-07
Date Mfgr Received2014-10-07
Date Added to Maude2014-11-19
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMS. KATHRYN CADORETTE
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927231
Manufacturer G1VTS MEDICAL SYSTEMS
Manufacturer Street40 MELVILLE PARK RD
Manufacturer CityMELVILLE NY 11747
Manufacturer CountryUS
Manufacturer Postal Code11747
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHARMONY IQ CUSTOM INTEGRATION SYSTEM
Generic NameINTEGRATION SYSTEM
Product CodeLMD
Date Received2014-11-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerVTS MEDICAL SYSTEMS
Manufacturer Address40 MELVILLE PARK RD MELVILLE NY 11747 US 11747


Patients

Patient NumberTreatmentOutcomeDate
10 2014-11-06

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