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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 Improper or Incorrect Procedure or Method (2017); Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/14/2019
Event Type  Injury  
Event Description
This incident was reported on 14 december 2019 from a facility in (b)(6) as reporter from facility states that there was air in the aorta of the patient during injection. Technical services seem to suspect a user error and not a malfunction and they have provided user training.
 
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Brand NameOPTIVANTAGE DH
Type of DeviceOPTIVANTAGE DH
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e galbraith road
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e galbraith road
cincinnati, OH 45237
MDR Report Key9580697
MDR Text Key174735894
Report Number1518293-2020-00001
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeFR
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
Type of Report Initial
Report Date 12/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received12/14/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/31/2011
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/13/2020 Patient Sequence Number: 1
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