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U.S. Department of Health and Human Services


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Model Number 844007
Device Problems Energy Output Problem (1431); Communication or Transmission Problem (2896)
Patient Problem Infiltration into Tissue (1931)
Event Date 11/03/2020
Event Type  malfunction  
Manufacturer Narrative
Service statement: "this service request was not sent to an engineer. It has remained in the tech support queue - cits. The customer did not request service at the time, because the error code only happened one time and she wanted to know what it meant or if it could have anything to do with a "possible infiltration" from the previous case, is what she said today" and "i called the customer to verify the information regarding the reported 1008 alarm. We did not find the alarm present in the alarm history. No further information is available regarding that error. I am not sure why it is not appearing in the results history as no other alarms have been reported by their staff since the reported 1008. " as of 17 november 2020, the support ticket is closed.
Event Description
This incident was reported by a facility in (b)(6) on (b)(6) 2020. A customer stated that the optivantage injector was displaying alarm 0x1008 - the console loses communication packets from the powerhead for more than 2 seconds. They stated that this is the only alarm that occurred and has been resolved by cycling the power on the system. This is a ceiling mounted powerhead, and the reporter checked the connections at the back of the power supply, the console, and the powerhead, and has stated that the alarm has not returned after rebooting the system. The reporter stated that this event occurred during a procedure, and that the patient was connected and experienced an infilatraion when the saline portion of the procedure could not be finished due to the alarm. The customer states that the procedure was completed by starting a new iv, and that there was no injury to staff.
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Type of DeviceINJ. OPTIV DH, W/OEM
Manufacturer (Section D)
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key10920351
MDR Text Key234409191
Report Number1518293-2020-00037
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Other Health Care Professional
Remedial Action Inspection
Type of Report Initial
Report Date 11/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844007
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage