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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM ANGIOMAT ILLUMENA

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LIEBEL-FLARSHEIM ANGIOMAT ILLUMENA Back to Search Results
Model Number 900001
Device Problems Component Missing (2306); Device Operates Differently Than Expected (2913)
Patient Problem Overdose (1988)
Event Type  malfunction  
Event Description
It was indicated by the biomed the injector prematurely injected and it is suspected too much contrast was delivered to the patient. (b)(6) discovered missing/broken pins located on the j2 connector of the communication board. This injector is interfaced with a (b)(6) system. I provided the p/n 901107-1sr to correct the issue.
 
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Brand NameANGIOMAT ILLUMENA
Type of DeviceANGIOMAT ILLUMENA
Manufacturer (Section D)
LIEBEL-FLARSHEIM
2111 e. galbraith rd
cincinnati OH 45237
Manufacturer Contact
fred reckelhoff
2111 e. galbraith rd
cincinnati, OH 45237
MDR Report Key6619598
MDR Text Key77282388
Report Number1518293-2017-00016
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Radiologic Technologist
Type of Report Initial
Report Date 06/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/07/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number900001
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 Received05/08/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/31/2013
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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