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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC

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TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC Back to Search Results
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2017
Event Type  malfunction  
Event Description
The fiber-optic component allows for an arterial pressure signal to be sent to the intra-aortic balloon pump (iabp) for a clean and fast signal to better support the patient. As a backup, a fluid filled transducer can also be used to time the iabp to support the patient. On this device, the fiber optic component was not functioning even after troubleshooting and calling technical support.
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key7171263
MDR Text Key96615253
Report Number7171263
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/19/2017,12/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/19/2017
Event Location Hospital
Date Report to Manufacturer12/19/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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