HARMONY IQ INTEGRATION SYSTEM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-24 for HARMONY IQ INTEGRATION SYSTEM manufactured by Black Diamond Video.

Event Text Entries

[118553293] During the procedure the image displayed on the monitor in the surgical room was not available. The harmony iq integration system required a restart subsequently causing a delay in the procedure. After the image was restored the patient procedure was completed successfully. No report of injury. A steris service technician arrived onsite to inspect the harmony iq integration system and found that the system's hard drive required replacement. The technician replaced the hard drive, tested the system, and confirmed it to be operating properly. No additional issues have been noted since replacement of the hard drive.
Patient Sequence No: 1, Text Type: N, H10


[118553294] The user facility reported that during a patient procedure their harmony iq integration system did not operate properly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008776287-2018-00005
MDR Report Key7814094
Date Received2018-08-24
Date of Report2018-08-24
Date of Event2018-07-26
Date Mfgr Received2018-07-26
Date Added to Maude2018-08-24
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 FDA3
Event Location3
Manufacturer ContactMR. DANIEL DAVY
Manufacturer Street5960 HEISLEY ROAD
Manufacturer CityMENTOR OH 44060
Manufacturer CountryUS
Manufacturer Postal44060
Manufacturer Phone4403927453
Manufacturer G1BLACK DIAMOND VIDEO
Manufacturer Street503 CANAL BLVD.
Manufacturer CityRICHMOND CA 94804
Manufacturer CountryUS
Manufacturer Postal Code94804
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHARMONY IQ INTEGRATION SYSTEM
Generic NameINTEGRATION SYSTEM
Product CodeKQM
Date Received2018-08-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerBLACK DIAMOND VIDEO
Manufacturer Address503 CANAL BLVD. RICHMOND CA 94804 US 94804


Patients

Patient NumberTreatmentOutcomeDate
10 2018-08-24

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