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U.S. Department of Health and Human Services

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

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TELEFLEX INCORPORATED ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL Back to Search Results
Model Number IPN000254
Device Problems Incorrect Or Inadequate Test Results (2456); Device Operates Differently Than Expected (2913)
Patient Problem High Blood Pressure/ Hypertension (1908)
Event Date 10/25/2017
Event Type  malfunction  
Event Description
Iabp fiber optic arterial line wave form began to read 200's systolic with a lot of artifact, but the sheath arterial line was reading 110's systolic which was reflective of what the patient looks like. I took pictures of screen. The iabp was switched to operator mode and is functioning properly now. No patient harm. Rn is talking with cath lab and making them aware of situation. I will save the catheter when removed from the patient this afternoon. I think that this might be a faulty catheter batch. Clinical engineering checked out the machine: functional checkout of machine is good. Fos sensor initial warmup took longer than normal(5 min). Turned off and let machine set for 1 hour and could not duplicate warm up time. Machine operated correctly with test set up and no pressure problems.
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
2400 bernville road
reading PA 19605
MDR Report Key7052704
MDR Text Key92779692
Report Number7052704
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 11/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN000254
Device Catalogue NumberIAB-05840-LWS
Device Lot NumberLM50417
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/03/2017
Event Location Hospital
Date Report to Manufacturer11/03/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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