MAUDE Adverse Event Report: LIEBEL-FLARSHEIM OPTIVANTAGE DH

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.

• Brand Name: OPTIVANTAGE DH
• Type of Device: OPTIVANTAGE DH
• Manufacturer (Section D): LIEBEL-FLARSHEIM; 2111 e galbraith road; cincinnati, oh
• Manufacturer Contact: fred reckelhoff ; 2111 e galbraith road; cincinnati, oh
• MDR Report Key: 10302770
• MDR Text Key: 213251628
• Report Number: 1518293-2020-00013
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 844001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1