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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 IPN915319
Device Problems Defective Device (2588); Reset Problem (3019); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Failure of Implant (1924)
Event Date 11/02/2021
Event Type  malfunction  
Event Description
Patient arrived from cath lab with teleflex intra-aortic balloon pump (iabp). On examination noted that the transducer was not zeroed. Called the company rep - instructed on a manual zero of the transducer. Checked the fos port- it is nonfunctional and defective. Teleflex rep will deliver replacement balloon - wants the defect balloon when it is removed for examination.
 
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Brand NameARROW
Type of DeviceSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key13009729
MDR Text Key282272665
Report Number13009729
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2021,11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN915319
Device Catalogue NumberIAB-05840-LWS
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2021
Date Report to Manufacturer12/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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