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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM OPTIVANTAGE DH

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LIEBEL-FLARSHEIM OPTIVANTAGE DH Back to Search Results
Model Number 844001
Device Problems Leak/Splash (1354); Device Difficult to Program or Calibrate (1496); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2019
Event Type  malfunction  
Manufacturer Narrative
Overall investigation summary incident: [(report (b)(4)) usage process: when the ct enhanced scan was performed, the high-pressure injector can be used normally at first, the patient was injected with medicament and during the subsequent bolus, the device alarmed suddenly, with red code "alert! 0x2048, 0x0042, 0x003, 0x00b, 0x0020" and other prompts on the display. The injection cannot be performed, the enhanced scan cannot be continued, the scanning failed, the machine tool can only be lowered, and the patient was temporarily removed from the ct room. Cause analysis description for the event: contrast media leaked into the faceplate due to the seal issue causing the device malfunction. Primary handling situation: follow-up high-pressure syringe in reserve was used for inspection,. ] (b)(4) engineering commented: "this error indicates that side b (0x0042) attempted to expel the piston past the positive limit. (0x0020) is the chipset offset for this error. Usually this error is associated with the need to calibrate the ram. " regional service "engineer reported the problem was fixed by replacing the powerhead pcb (ass'y, 844375-1s). System is normal now. " cts history search shows no other similar issues with this unit. Root / probable cause code: materials: contamination. Root / probable cause summary: see failure mode (see components and overall investigation summary). No further investigation needed at this time. Qa will continue to monitor and trend for similar issues. No capa at this time, these trends and issues are reported on during quality metrics reviews and during the management review meetings to consider input for corrective action. Disposition summary: the problem was fixed by replacing the powerhead pcb (ass'y, 844375-1s). System normal now.
 
Event Description
This incident was reported by a representative of (b)(6) hospital on 24 june 2020. This incident occurred on (b)(6) 2019. It was reported that the usp and top slot was detached when use. Under the circumstance, the product was sealed and never used anymore. Harm: serious injury/manifestation of injury: the syringe couldn't work properly, and the patient's examination was suspended. Device malfunction manifested by: ct prompted alarm, syringe cannot work and enhanced scan was stopped. Intended therapeutic disease or effect: obtain patient image information and provide reference to clinic. Usage process: on tuesday, at 10:00 am of (b)(6) 2019, when the ct enhanced scan was performed at the department of radiology, the high-pressure injector can be used normally at first, the patient was injected with medicament and during the subsequent bolus, the device alarmed suddenly, with red code "alert! 0x2048 (these mean that the injector believes that certain values are not the same on the powerhead and console). , 0x0042 (injector not calibrated properly). , 0x003 (console ram failure), 0x00b, 0x0020" and other prompts on the display. The injection cannot be performed, the enhanced scan cannot be continued, the scanning failed, the machine tool can only be lowered, and the patient was temporarily removed from the ct room. Cause analysis of the event: product reasons (including instructions for use, etc. ) cause analysis description for the event: contrast media leaked into the faceplate due to the seal issue causing the device malfunction.
 
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Brand NameOPTIVANTAGE DH
Type of DeviceOPTIVANTAGE DH
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e galbraith road
cincinnati, oh
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, oh 
MDR Report Key10302770
MDR Text Key213251628
Report Number1518293-2020-00013
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K063503
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 Repair
Type of Report Initial
Report Date 06/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2020
Is this a Product Problem Report? Yes
Device Operator
Device Model Number844001
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 Received06/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2014
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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