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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIEBEL-FLARSHEIM OPTIVANTAGE WITH PEDESTAL

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LIEBEL-FLARSHEIM OPTIVANTAGE WITH PEDESTAL Back to Search Results
Model Number V8401
Device Problem Self-Activation or Keying (1557)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2017
Event Type  malfunction  
Event Description
The equipment is starting the injections by itself.
 
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Brand NameOPTIVANTAGE WITH PEDESTAL
Type of DeviceOPTIVANTAGE WITH PEDESTAL
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 Key6275805
MDR Text Key66003500
Report Number1518293-2017-00002
Device Sequence Number1
Product Code IZQ
Combination Product (y/n)N
Reporter Country CodeBR
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 01/25/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberV8401
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 Received01/09/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/30/2007
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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