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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BLACK DIAMOND VIDEO HARMONY IQ INTEGRATION SYSTEM
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BLACK DIAMOND VIDEO HARMONY IQ INTEGRATION SYSTEM Back to Search Results
Device Problem No Display/Image (1183)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/23/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmony iq integration system and found that the power box had failed causing the inability to route video onto the monitor screen.The technician replaced the power supply, tested the unit, confirmed it to be operating according to specifications, and returned the unit to service.The power supply is being returned to steris for evaluation.A follow-up mdr will be submitted should additional information become available.
 
Event Description
The user facility reported that during a patient procedure the monitor connected to their harmony iq integration system went blank.A procedure delay occurred as the facility had to reroute the power to the monitor to complete the procedure.The procedure was completed successfully; no report of injury.
 
Manufacturer Narrative
An evaluation of the returned power supply was conducted by steris engineering; however, a specific root cause could not be determined.The reported issue is an isolated event.No additional issues have been reported.
 
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Brand Name
HARMONY IQ INTEGRATION SYSTEM
Type of Device
HARMONY IQ INTEGRATION SYSTEM
Manufacturer (Section D)
BLACK DIAMOND VIDEO
503 canal blvd.
richmond CA 94804
MDR Report Key9497155
MDR Text Key217726989
Report Number3008776287-2019-00002
Device Sequence Number1
Product Code KQM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 12/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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