MAUDE Adverse Event Report: LIEBEL-FLARSHEIM ANGIOMAT ILLUMENA

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.

• Brand Name: ANGIOMAT ILLUMENA
• Type of Device: ANGIOMAT 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 Key: 6619598
• MDR Text Key: 77282388
• Report Number: 1518293-2017-00016
• Device Sequence Number: 1
• Product Code: IZQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063503
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 900001
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2017
• Date Device Manufactured: 10/31/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1